BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 5585901 · Received April 18, 2016

    Report

    Report Number
    9610617-2016-00062
    Event Type
    Malfunction
    Date Received
    April 18, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 16, 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 INDICATED 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 JAW BROKE OFF INTO PATIENT DURING THE PROCEDURE. THE DOCTOR RETRIEVED PIECE AND COMPLETED PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239021 BOWEL GRASPER BOWEL GRASPER FCL KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 33310C GM

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention