BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3881682 · Received May 19, 2014

    Report

    Report Number
    9610617-2014-00020
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 17, 2014
    Manufacturer
    KARL STORZ GMBH & CO
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL 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 OUT IFU WARNS AGAINST.

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE THE DOCTOR WAS PERFORMING A LAPAROSCOPIC BOWEL RESECTION, ONE OF THE JAWS BROKE OFF INTO THE PT. THE DOCTOR VISUALIZED, RETRIEVED AND REMOVED THE BROKEN JAW FROM PT. PROCEDURE WAS COMPLETED; NON INJURY TO THE PT REPORTED. PT CONDITION GOOD POSTOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295834 KARL STORZ BOWEL GRASPER GCJ KARL STORZ GMBH & CO 33310C TZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention