BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 5556038 · Received April 7, 2016

    Report

    Report Number
    9610617-2016-00040
    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 OVERSTRESS; 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 LOWER ANTERIOR RESECTION OF THE COLON WHEN HE NOTICED THAT THE JAW HAD BROKEN OFF THE GRASPER INTO THE PATIENT. THE DOCTOR IMMEDIATELY RETRIEVED THE PIECE. HOSPITAL REPORTS THAT PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211026 BOWEL GRASPER BOWEL GRASPER FCL KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 33310C OZ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention