BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 5556054 · Received April 7, 2016

    Report

    Report Number
    9610617-2016-00041
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 8, 2016
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    FCL
    PMA / PMN Number
    K935070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED THAT ONE JAW WAS BROKEN OFF THE INSTRUMENT. THE MOST LIKELY CAUSE FOR THIS KIND OF DAMAGE IS STRESS OVERLOAD; GRASPER JAW WAS USED TO HOLD TOO MUCH WEIGHT OR DEVICE WAS USED FOR RETRACTING HEAVY TISSUE. WE CANNOT CONFIRM.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A LAPAROSCOPIC APPENDECTOMY WHEN HE NOTICED THE JAWS OF THE GRASPER NOT FUNCTIONING. HE LOOKED AT MONITOR AND NOTED THAT THE JAW HAD BROKEN OFF INTO THE PATIENT. HE ORDERED IMAGING BUT COULD NOT FIND THE PIECE. HE CONTINUED WITH AND COMPLETED PROCEDURE. HE THEN HAD AN X-RAY TAKEN OF THE PATIENT AFTER THE PROCEDURE WHERE HE WAS ABLE TO LOCATE THE JAW. HE BROUGHT THE PATIENT BACK INTO OR AND USING AN ALREADY CREATED PORT FROM THE APPENDECTOMY REMOVED THE PIECE BY MEANS OF LAPARATOMY. HOSPITAL STATES THERE WAS NO INJURY CAUSED TO THE PATIENT AND PATIENT CONDITION WAS GOOD POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215977 BOWEL GRASPER BOWEL GRASPER FCL KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 33310C SY

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention