BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORSEY INTESTINAL GRASPING FORCEPS

    MDR report key: 9670416 · Received February 5, 2020

    Report

    Report Number
    9681129-2020-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    December 10, 2019
    Report Date
    February 5, 2020
    Manufacturer
    BEMA GMBH & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K102921
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ACCORDANCE WITH BENCH TESTING RESULTS, THE TYPE OF MALFUNCTION OBSERVED IN THIS CASE OCCURS WHEN EXCESSIVE STRESS IS EXERTED ON THE INSTRUMENT. IT IS THEREFORE POSSIBLE THAT THE INTESTINAL FORCEPS WAS USED INAPPROPRIATELY DURING THE HYSTERECTOMY TO HOLD OR MANIPULATE AN ORGAN OTHER THAN THE INTESTINE. DETACHMENT OF THE LOCKING PINS DOES NOT ALWAYS IMMEDIATELY PREVENT THE FORCEPS JAW FROM OPENING AND CLOSING AS INTENDED. IT IS THEREFORE CONCEIVABLE THAT THE PINS FELL OUT OF THE FORCEPS OUTSIDE THE SURGICAL FIELD AND THAT THE FORCEPS CONTINUED TO BE USED UNTIL IT FAILED. THIS WOULD EXPLAIN THAT NOTHING WAS FOUND BY THE X-RAY. NO PROBLEMS WERE DETECTED IN THE PRODUCTION RECORDS OF THE INSTRUMENT NOR ANY OF ITS COMPONENTS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THE PAST.

    Description of Event or Problem · 1

    DURING A ROBOTIC HYSTERECTOMY, THE JAW COMPONENTS OF THE FORCEPS CEASED TO FUNCTION APPARENTLY DUE TO MISSING CONNECTION PINS. AN X-RAY WAS TAKEN TO ENSURE THAT THE PINS HAD NOT FALLEN INTO THE PATIENT'S ABDOMINAL CAVITY. NOTHING WAS FOUND. THE PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT'S OUTCOME WAS GOOD, TO OPERATING ROOM STAFF KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134222 DORSEY INTESTINAL GRASPING FORCEPS GRASPING FORCEPS GEI BEMA GMBH & CO. KG 73335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention