BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 957300 · Received December 5, 2007

    Report

    Report Number
    9610773-2007-00027
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 6, 2007
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CABLE DETACHED IN TWO PIECES AT THE ELECTROSURGICAL CONNECTOR END DUE TO EXCESSIVE FORCE. BOTH ENDS OF THE CABLE SHOWED EVIDENCE OF THERMAL DAMAGE, LIKELY DUE TO ARCHING FROM THE ELECTROSURGICAL GENERATOR OUTPUT. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, BASED UPON THE CONDITION OF THE DEVICE, USER HANDLING LIKELY CONTRIBUTED TO THE REPORTED EVENT. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), AS THE PHYSICIAN WAS ACTIVATING THE OLYMPUS RESECTION ELECTRODE TO CUT THE PATIENT, SPARKS EMITTED FROM THE CABLE AT THE PROXIMAL END, NEAR THE NON-OLYMPUS ELECTROSURGICAL GENERATOR. THE SPARKS WERE QUICKLY EXTINGUISHED, AND THERE WAS NO USER OR PATIENT INJURY; THE PATIENT HAD NOT BEEN CUT YET. THE PROCEDURE WAS DELAYED WHILE A REPLACEMENT CABLE WAS OBTAINED, THEN COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY CABLE KNS OLYMPUS WINTER & IBE GMBH A0393 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR