BEUDAMED
    FDA Adverse Event Other Summary report: N

    33CM PKS CUTTING FORCEPS, 5MM

    MDR report key: 1579903 · Received January 13, 2010

    Report

    Report Number
    2183680-2009-00138
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 13, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTING FORCEPS WERE RECEIVED WITH A REPROCESSING STICKER ON THE HANDLE. IT WAS REPROCESSED BY (B)(6). (THE FACILITY HAS BEEN INFORMED THAT THIS DEVICE IS A SINGLE USE DEVICE). THERE IS NO EVIDENCE OF WEAR MARKS OF THE ELECTRODE INSULATION AND THE FLARE IS INTACT. THE DEVICE WORKED MECHANICALLY AS DESIGNED. THE REUSABLE CORD WAS RETURNED WITH THE CUTTING FORCEPS. A VISUAL INSPECTION FOUND THAT THE GENERATOR PLUG CONNECTOR IS VERY CORRODED. THERE ARE NO BREAKS OR CUTS IN THE RUBBER INSULATION OF THE CORD. THE CORD WAS ATTACHED WITH THE DEVICE TO THE GENERATOR. THE DEVICE DISPLAYED THE CORRECT DEFAULTS, VP3-3 WHEN ACTIVATED AND IT COAGULATED THE TEST SAMPLE WITH NO HEATING OF THE SHAFT OBSERVED. THE POWER SETTING WAS INCREASED TO THE MAX (VP3-50), IT AGAIN COAGULATED THE TEST SAMPLE FOR AN EXTENDED PERIOD OF TIME WITH NO HEATING OF THE SHAFT OBSERVED. THE COMPLAINT CANNOT BE CONFIRMED THAT THE DEVICE CAUSED A BURN AT THE INSERTION SITE.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TUBAL LIGATION PROCEDURE USING OUR PK CUTTING FORCEPS AND PK CORD, THE SURGEON NOTICED THAT THE PATIENT HAD A BURN AROUND THE INCISION WHERE THE CANNULA WAS INSERTED. THE BURN WAS NOT SEVERE ENOUGH TO REQUIRE TREATMENT, AND THERE WAS NO LONGER HOSPITALIZATION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM PKS CUTTING FORCEPS, 5MM PKS CUTTING FORCEPS, 5MM, 33CM GEI GYRUS MEDICAL, INC. 3005PK3 7339069

    Patients

    Seq Age Sex Outcome Treatment
    1