BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI FIRE ENDO GIA 30

    MDR report key: 176125 · Received July 2, 1998

    Report

    Report Number
    MW1014155
    Event Type
    Malfunction
    Date Received
    July 2, 1998
    Date of Event
    June 10, 1998
    Report Date
    June 10, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO GIA 30-2.5 AUTO SUTURE REMOVED FROM LAPAROSCOPIC TROCAR & HANDED TO OR TECH TO REFILL. REFILLED & THEN OR TECH NOTED THE 2-3 MM CIRCULAR DISCHARGE BUTTON WAS MISSING FROM THE SHAFT OF THE DEVICE. ITEM IS MADE OF TITANIUM. REMAINS IN THE PELVIC AREA OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI FIRE ENDO GIA 30 DISPOSABLE STAPLE GAG UNITED STATES SURGICAL CORP. NA P8C40

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other