BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 5704692 · Received June 7, 2016

    Report

    Report Number
    9610617-2016-00090
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 10, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WHICH OUR IFU WARNS AGAINST. WE CANNOT CONFIRM.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING LAPAROSCOPIC APPENDECTOMY AND WHEN HE WENT TO GRASP SOMETHING HE NOTED THE INSTRUMENT WAS NOT FUNCTIONING. WHEN HE REMOVED THE INSTRUMENT HE SAW THAT ONE JAW WAS BROKEN OFF THE GRASPER. HE HAD AN X-RAY DONE AND CONFIRMED THE LOCATION OF THE MISSING PIECE IN THE OMENTUM. HE CREATED A PORT AND IMMEDIATELY REMOVED THE PIECE. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358097 BOWEL GRASPER BOWEL GRASPER FCL KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 31110C OU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention