BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 4455676 · Received January 16, 2015

    Report

    Report Number
    9610617-2015-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 18, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOWEL GRASPER INSERT WAS EVALUATED, AND WE CONFIRMED ONE OF THE JAWS IS BROKEN OFF. THE INSTRUMENT WAS MANUFACTURED IN JUNE 2011; IT HAS BEEN IN USE FOR THREE YEARS. THE MOST LIKELY CAUSE FOR THIS KIND OF DAMAGE IS OVERSTRESS. IE GRASPER JAWS WERE 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, DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, ONE OF THE JAWS ON INSTRUMENT BROKE OFF INTO THE PT. THE DOCTOR WAS ABLE TO RETRIEVE BROKEN PIECE. PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40419 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. KG 33310C TY

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention