BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 526727 · Received May 21, 2004

    Report

    Report Number
    1219930-2004-00130
    Event Type
    Malfunction
    Date Received
    May 21, 2004
    Date of Event
    April 22, 2004
    Report Date
    May 6, 2004
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE INSTRUMENT RELEASED THE NEEDLE WHILE PASSING IT THROUGH THE JAWS AND COULD NOT BE RETRIEVED FROM STOMACH. A NEW INSTRUMENT WAS LOADED AND USED TO COMPLETE THE CASE. PT STATUS: NO INJURY. PROCEDURE: LGB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE ENDOSCOPIC INSTRUMENT GCJ NORTH HAVEN - USS NA N3L383

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN