BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3830089 · Received May 7, 2014

    Report

    Report Number
    9610617-2014-00013
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GEI
    PMA / PMN Number
    K954122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS EVALUATED AND WE CONFIRMED THAT A SMALL SLICE OF INSULATION WAS MISSING FROM THE SHAFT. IT IS POSSIBLE THE INSULATION WAS GOUGED WHEN IT CAME INTO CONTACT WITH ANOTHER INSTRUMENT RESULTING IN A TEAR. ALSO, THE TROCAR SENT IN WITH THIS INSTRUMENT HAD NICKS AND DENTS ON THE DISTAL END THAT MAY HAVE CAUGHT THE INSULATION WHEN THE INSTRUMENT WAS INTRODUCED. OTHER THAN THE MISSING INSULATION, THE DEVICE FUNCTIONED FINE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A LAP CHOLE PROCEDURE, THE DOCTOR NOTICED AT THE END OF THE PROCEDURE THAT THERE WAS A PIECE OF INSULATION MISSING FROM THE SHAFT OF INSTRUMENT. THE DOCTOR EXAMINED PATIENT, VISUALIZED MISSING PIECE AND RETRIEVED AND REMOVED. THE PROCEDURE WAS COMPLETED; THERE WAS NO IMPACT ON PATIENT. PATIENT CONDITION POST-OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274884 KARL STORZ OUTER TUBE WITH WORKING INSERT GEI KARL STORZ GMBH & CO. 30710FG ZX

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention