BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2158652 · Received July 2, 2011

    Report

    Report Number
    9610617-2011-00028
    Event Type
    Other
    Date Received
    July 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GRASPER JAWS ARE NOT FUNCTIONING BECAUSE ONE HINGE IS NOT ATTACHED; THE 1MM PIECE OF PIN THAT SECURED THE HINGE IS MISSING. DAMAGE MAY BE DUE TO STRESS OVERLOAD.

    Description of Event or Problem · 1

    ALLEGEDLY, DOCTOR WAS PERFORMING A LAPAROSCOPIC REPAIR ON AN APPENDIX RUPTURE WHEN THE JAW BROKE AND STOPPED FUNCTIONING. DOCTOR WAS CONCERNED THAT A PIECE MAY HAVE COME OFF INSTRUMENT SO HE DID AN X-RAY; THE X-RAY RESULTS WERE NEGATIVE. DOCTOR REPLACED INSTRUMENT AND COMPLETED PROCEDURE; PATIENT'S CONDITION POST-OP WAS GOOD. UPON RETURN OF INSTRUMENT, OUR EVALUATION SHOWED THAT A LESS THAN 1MM PIECE OF HINGE PIN WAS MISSING; IT IS POSSIBLE PIECE REMAINS IN PATIENT; IT IS ALSO POSSIBLE THE PIECE CAME OFF WHEN INSTRUMENT WAS OUTSIDE OF PATIENT DURING REMOVAL. WE INFORMED HOSPITAL OF FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ OUTER TUBE WITH GRASPER GCJ KARL STORZ GMBH & CO. KG 30340AS HB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other