BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO GIA 30

    MDR report key: 68542 · Received February 13, 1997

    Report

    Report Number
    MW1010731
    Event Type
    Malfunction
    Date Received
    February 13, 1997
    Date of Event
    February 5, 1996
    Report Date
    February 23, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE STAPLERS WERE IDENTIFIED AS WORKING IMPROPERLY. ADD'L CAT # 030811 30-2.5, LOT # P4C182, EXP 4/99. CAT # 030813 30-3.5, LOT NO P5D259J EXP 2000-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30 DISPOSABLE STAPLER GAG UNITED STATES SURGICAL CORP. AUTO SUTURE MULTIFIRE ENDO GIA P4M96

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other