BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 3925184 · Received June 20, 2014

    Report

    Report Number
    9610617-2014-00030
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED. THE MOST LIKELY CAUSE FOR THIS KIND OF DAMAGE IS OVERSTRESS; GRASPER JAW WAS USED TO HOLD TOO MUCH WEIGHT OR DEVICE WAS USED FOR RETRACTING HEAVY TISSUE WHICH OUR IFU WARNS AGAINST.

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE PERFORMING A LAP HERNIA REPAIR, ONE JAW OF THE INSTRUMENT BROKE OFF INTO THE PATIENT. THE DOCTOR IMMEDIATELY RETRIEVED THE JAW. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363532 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. 33310C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention