BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 4379200 · Received December 23, 2014

    Report

    Report Number
    9610617-2014-00067
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 24, 2014
    Report Date
    November 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THIS KIND OF DAMAGE IS OVERSTRESS, I.E. GRASPER JAWS WERE 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, NEAR THE BEGINNING OF A LAPAROSCOPIC APPENDECTOMY PROCEDURE, ONE JAW OF THE INSTRUMENT BROKE OFF INTO THE PATIENT. THE DOCTOR WAS NOT IMMEDIATELY ABLE TO LOCATE AND RETRIEVE THE JAW AND PROCEEDED TO REMOVE THE APPENDIX, AFTER WHICH AN X-RAY WAS PERFORMED AND THE MISSING JAW WAS LOCATED AND RETRIEVED; THIS PROLONGED THE PROCEDURE BY APPROXIMATELY 90 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848870 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. 33310C TY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention