BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 1990033 · Received February 9, 2011

    Report

    Report Number
    MW5019395
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 13, 2010
    Report Date
    February 9, 2011
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER 4TH RELOAD, THE (B)(4) STILL WOULD NOT FIRE. NO HARM TO PT. PROCEDURE: LAPAROSCOPIC ILEOCOLIC RESECTION. SURGEON: DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE GIA80 3.8MM RELOADABLE STAPLER GDW COVIDIEN SURGICAL DEVICES GIA8038S POK1203

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR