BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 4486476 · Received January 29, 2015

    Report

    Report Number
    9610617-2015-00008
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 7, 2015
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED THAT ONE JAW HAS BROKEN OFF THE DISTAL END FROM 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 PROCEDURE, ONE JAW OF THE INSTRUMENT BROKE OFF AND FELL INTO THE PT. THE DOCTOR IMMEDIATELY RETRIED THE JAW. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66049 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention