• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—May 21

    Iterative Scopes Expands its Senior Leadership Team

    Viz.ai Raises $100 Million in Series D Funding

    FDA Clears Arterys' AI Mapping and Quantification Tools

    Prometheus Group Sued Over Reused Catheters and Rectal Sensors
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    BMP Medical

    Cirtec Medical

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    BMP Medical

    Cirtec Medical

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA to Closely Examine Surgical Stapler Risks

    The agency is aware of an increasing number of reports associated with surgical staplers for internal use and implantable surgical staples.

    Related CONTENT
    • Ethicon Launches Echelon+ Stapler
    • The FDA Wants to Bring Manufacturing ‘Home’
    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    • FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    • FDA OKs Masimo’s Rad-G Pulse Oximeter
    U.S. Food and Drug Administration03.11.19
    The U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and to provide updated recommendations to help reduce risks associated with their use. The letter also includes information about additional actions the agency is planning in the coming months to address the devices’ safety, including issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.
     
    “As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health. “As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective. The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk. We are asking providers to be aware of the new information and implement the recommendations we’re outlining today to help improve the safe use of these devices. Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”
     
    Surgical staplers and staples may be indicated for use in a wide range of surgical applications, including gastrointestinal, gynecologic, and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures. These devices facilitate surgical procedures and may shorten surgical procedure time compared to manual suturing. Currently, surgical staplers are regulated as Class I medical devices, which do not require a premarket submission to the FDA. Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.
     
    The agency has issued previous communications about the risks involved with surgical staplers and implantable staples and has been conducting an ongoing assessment of medical device reports (MDRs) filed with the agency. The agency’s analysis shows that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions. The FDA continues to evaluate the MDRs for these devices.
     
    The most commonly reported problems in these adverse event reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue). Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
     
    In today’s communication, the FDA is reminding providers to review labeling instructions and indications for use for surgical staplers and implantable staples, such as choosing the appropriate staple size for the patient’s tissue type and thickness. The letter to healthcare providers also suggests considering alternative options if the patient’s tissues are swollen, prone to bleeding, or dead (necrotic). The FDA further provides recommendations on how to recognize and manage device malfunction.
     
    For patients, it is important to understand that when used correctly, surgical staplers and staples can be beneficial surgical tools. These devices are regularly used in many types of surgical cases, and enable a surgeon to perform a less invasive operation, which may reduce postoperative pain and shorten recovery time. The types of adverse events observed with surgical staplers and staples may similarly occur with hand sewn alternatives. The purpose of the letter to healthcare providers is to remind them of the importance of appropriate selection and use of surgical staplers and staples to mitigate risk.
     
    In addition to the letter to healthcare providers, the agency is taking steps to address the safety of these devices.
     
    The FDA intends to issue a new draft guidance for public comment this year, which will describe proposed recommendations for manufacturers of surgical staplers and staples for internal use about information to include in their product labeling, which will help healthcare providers better understand the appropriate use and the risks of these products.
     
    In light of the identified risks of surgical staplers, the agency also intends to hold a public meeting of the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee this year to discuss whether the current pathway for manufacturers to market surgical staplers is appropriate. As part of the panel meeting, the FDA will present a comprehensive analysis of all the MDRs received for surgical staplers and staples for internal use, as well as other relevant information, and will seek panel input on whether reclassifying surgical staplers for internal use is appropriate. Reclassifying surgical staplers for internal use from Class I to Class II would allow the FDA to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension (assessing user’s ability to properly select and use the device according to the labeling), and specific labeling elements supporting the safe use of the device.
     
    The FDA will announce the meeting, including details about how to participate, on the FDA Advisory Committee calendar webpage and in a Federal Register notice at a future date.
     
    The communication issued today reflects the agency’s commitment to advancing policies that enhance the FDA’s oversight of medical device safety. As part of the Medical Device Safety Action Plan, the FDA has alerted the public when safety issues are identified, such as duodenoscopes, breast implant-associated anaplastic large cell lymphoma, and unsafe silicone injections. The agency is also working with stakeholders to develop patient registries, including the National Evaluation System for health Technology, to provide more complete evidence in clinical areas to enhance the agency’s ability to identify and act upon safety issues with medical devices.
     
    As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with surgical staplers and implanted staples. We will keep the public informed if significant new information becomes available. We encourage patients, providers and healthcare facilities to report adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
    Related Searches
    • implant
    • user
    • labeling
    • technology
    Related Knowledge Center
    • Surgical
    Suggested For You
    Ethicon Launches Echelon+ Stapler Ethicon Launches Echelon+ Stapler
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence
    Acutus AcQMap Catheter Cleared by FDA Acutus AcQMap Catheter Cleared by FDA
    FDA OKs Varian FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test
    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data
    HD Medical Awarded FDA Clearance for HD Steth HD Medical Awarded FDA Clearance for HD Steth
    FDA OKs Minnetronix FDA OKs Minnetronix's MindsEye Neurosurgical Access Platform

    Related Content

    • Surgical
      Ethicon Launches Echelon+ Stapler

      Ethicon Launches Echelon+ Stapler

      Increases staple line security and reduces complications in surgery.
      Charles Sternberg, Assistant Editor 04.01.21

    • Contract Manufacturing
      The FDA Wants to Bring Manufacturing ‘Home’

      The FDA Wants to Bring Manufacturing ‘Home’

      The agency commissioners comment how the need to modernize the critical medical supply chain is long overdue.
      Sean Fenske, Editor-in-Chief 10.01.20

    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device

      RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device

      The approval will enable the company to initiate a clinical study of the products for safety and feasibility.
      Globe Newswire 09.30.20


    • Cardiovascular | Surgical
      FDA OKs SentiAR

      FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System

      Allows electrophysiologists to visualize 3D electroanatomic models in real-time, via a wearable headset.
      PR Newswire 09.30.20

    • Patient Monitoring
      FDA OKs Masimo’s Rad-G Pulse Oximeter

      FDA OKs Masimo’s Rad-G Pulse Oximeter

      Rugged handheld device provides clinically proven Masimo SET pulse oximetry and respiration rate monitoring.
      Business Wire 09.28.20


      Trending
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Smart LED Contact Lens Diagnoses Diabetes & Treats Retinopathy | Medical Product Outsourcing
      • FDA Clears Innovia Medical's Sterizone VP4 Sterilization Process | Medical Product Outsourcing
      • Medtronic's Onyx Frontier Drug-Eluting Stent Earns FDA Nod | Medical Product Outsourcing
      • Medtronic's Resolute Onyx Drug-Eluting Stent Shows Success For Left Main PCI | Medical Product Outsourcing
      Breaking News
      • MPO's Most-Read Stories This Week—May 21
      • Iterative Scopes Expands its Senior Leadership Team
      • Viz.ai Raises $100 Million in Series D Funding
      • FDA Clears Arterys' AI Mapping and Quantification Tools
      • Prometheus Group Sued Over Reused Catheters and Rectal Sensors
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
      Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
      Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission
      Coatings World

      Latest Breaking News From Coatings World

      Teknos Receives EcoVadis Gold Medal for Sustainability Performance
      AkzoNobel and Partners Team Up to Hack Carbon Reduction Challenges
      Five PPG Facilities in Ohio Recognized for Sustainability, Health, Safety Practices
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—May 21
      Iterative Scopes Expands its Senior Leadership Team
      Viz.ai Raises $100 Million in Series D Funding
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Piramal Pharma Solutions New API Plant in Canada Now Online
      MG America Appoints Claudio Radossi as President
      Catalent Invests $175M to Expand Mfg. Capabilities at Winchester, KY
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Authentic Beauty Concept Launches Second-Generation ‘Refill Bar’
      HASK Beauty Enters Exclusive Partnership with Amazon
      Garance Doré Launches Made in France Skincare Line
      Happi

      Latest Breaking News From Happi

      SPF Setting Spray, Lip Contour and Knotless Braids Are Hot Trends: Spate
      Nutrafol Launches Collagen Infusion
      ÄZ Craft Luxury Haircare Products Support All Hairstyles
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Specialty announces move to new facility
      Mark Andy hosts dealer's open house in Warsaw
      Nazdar celebrates 100th anniversary with refreshed brand identity
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      3M to Expand in Nebraska
      Nicely Offers Nonwoven Slitters, Winders
      'Right' Hygiene Conference to be Held in June
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login