BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35MM TITAN HEMORRHOID STAPLER

    MDR report key: 12040445 · Received June 21, 2021

    Report

    Report Number
    MW5102002
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 16, 2021
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN 35MM TITAN HEMORRHOID STAPLER (REF HEM3335, LOT N0L0413Y) MALFUNCTION AFTER STAPLER WAS PLACED IN PATIENT'S SURGICAL SITE. SURGEON STATED THE STAPLER WOULD NOT CLOSE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934191 35MM TITAN HEMORRHOID STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN N0L0413Y

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR