BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 4486477 · Received January 29, 2015

    Report

    Report Number
    9610617-2015-00009
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    November 11, 2014
    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 TOOK AN X-RAY AND IMMEDIATELY RETRIEVED THE JAW. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66219 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. KG 33410C OW

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention