BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 3966163 · Received June 4, 2014

    Report

    Report Number
    9610617-2014-00025
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 5, 2014
    Manufacturer
    KARL STROZ GMBH AND CO
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED THAT ONE JAW HAS 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 WHICH OUR IFU WARNS AGAINST.

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE PERFORMING A LAPAROSCOPIC APPENDECTOMY, THE DOCTOR INTRODUCED THE GRASPER TOO QUICKLY THROUGH THE TROCAR CAUSING IT TO CATCH RESULTING IN ONE JAW BREAKING OFF INTO PT. DOCTOR IRRIGATED THE PT AND TOOK AND X-RAY AFTER THE PROCEDURE TO CONFIRM THAT THE JAW WAS FLUSHED OUT AND NOTHING REMAINED. PROCEDURE WAS COMPLETED WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325634 BOWEL GRASPER BOWEL GRASPER GCJ KARL STROZ GMBH AND CO 33310C ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention