BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE

    MDR report key: 12083887 · Received June 29, 2021

    Report

    Report Number
    12083887
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    December 22, 2020
    Report Date
    June 14, 2021
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAPLER DID NOT FIRE. MANUFACTURER RESPONSE FOR RELOAD SIGNIA TRA STAPLE 60 PU X 3, (BRAND NOT PROVIDED) (PER SITE REPORTER). IT WAS PICKED UP BY FIELD REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984173 TRI-STAPLE STAPLE, IMPLANTABLE GDW COVIDIEN SIGTRSB60AMT NOF1046Y

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA