BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 1900972 · Received November 11, 2010

    Report

    Report Number
    MW5018197
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE LAPAROSCOPIC CASE, THE ENDOCATCH POUCH STRIPPED OFF WHILE BEING TAKEN OUT OF THE ABDOMEN. THE SPECIMEN FELL BACK INTO THE ABDOMEN. NO ADVERSE EFFECT ON THE PT. DR (B)(6), DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO CATCH GOLD 10MM GCJ COVIDIEN SURGICAL DEVICES 173050G JOH0044

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR