BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOSUTURE ENDO CLIP II

    MDR report key: 12061 · Received March 16, 1994

    Report

    Report Number
    MW1001106
    Event Type
    Other
    Date Received
    March 16, 1994
    Date of Event
    March 1, 1994
    Report Date
    March 2, 1994
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GDO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE MISFIRED DURING LAPAROSCOPIC CHOLECYSTECTOMY. SURGEON PULLED TRIGGER AND APPLIER DID NOT "FIRE" (EJECT STAPLE). NO INJURY/HARM TO PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO CLIP II GDO UNITED STATES SURGICAL CORP. U4A34

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other