BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3944468 · Received May 9, 2014

    Report

    Report Number
    9610617-2014-00016
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 8, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GWG
    PMA / PMN Number
    K001630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICAL INSPECTION REVEALED BADLY WORN AND CRACKED INSULATION WHERE JAWS MEET STEEL SHAFT. ALSO, INDICATIONS OF HEAT DAMAGE OF INSULATION. BOTH JAWS FAILED RESISTANCE CONTINUITY TEST AND FAILED HIGH POT TESTING. APPEARANCE IS OF AN INSERT THAT IS WORN OUT AND USED PAST ITS USEFUL LIFE. THE DEVICE HAS BEEN IN USE FOR APPROXIMATELY 6 YEARS.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE END OF A HYPOPHYSECTOMY PROCEDURE, THE DOCTOR WENT TO COAGULATE BLEEDERS AND THE INSTRUMENT WOULD NOT ACTIVATE. HE TRIED TWO MORE INSTRUMENTS WHICH WOULD ALSO NOT ACTIVATE. HE THEN FOUND AN INSTRUMENT THAT ACTIVATED AND COMPLETED PROCEDURE. THERE WAS NO PT INJURY AND PT CONDITION POST-OP WAS GOOD. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280996 KARL STORZ BIPOLAR FORCEPS - 84G-WG GWG KARL STORZ GMBH & CO. KG 28164FGM EB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention