BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CUTTING LOOP ELECTRODE - DEVICE #3

    MDR report key: 2823688 · Received September 3, 2010

    Report

    Report Number
    1418479-2010-00024
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 3, 2010
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: (B)(4) - BIPOLAR COAGULATING ELECTRODE. VISUAL INSPECTION CONFIRMED THE WIRE LOOP BREAKAGE. HEAVY BURN MARKS WERE EVIDENT ON BOTH WIRE LOOPS. BLUE INSULATION WAS MELTED. USER FACILITY CONFIRMED THAT THIS PROCEDURE WAS EITHER THE FIRST OR SECOND ONE THAT THE SURGEON HAD PERFORMED WITH THE RICHARD WOLF ELECTRODES. WE WERE INFORMED THAT THE SURGEON, CIRCULATING NURSE AND A TECH WAS IN THE ROOM FOR THE PROCEDURE. THERE WAS NO RICHARD WOLF SALES REP THERE FOR THIS PROCEDURE. THE FACILITY DID NOT PROVIDE A LOT NUMBER FOR THE ELECTRODES. CAUSE OF EVENT: A HIGH ELECTROSURGICAL SETTING WAS USED. IN ADDITION, THE SURGEON MUST BE MINDFUL OF THE SPEED OF RESECTION. TECHNIQUE SERVICES AS THE CAUSE OF THE DEVICE FAILURE. WE HAVE ADDRESSED THIS VIA LETTER TO THE FACILITY. IN ADDITION, OUR CURRENT SALES REP IS CLOSELY INVOLVED WITH THE FACILITY AND WILL ASSIST WITH THEIR NEEDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, FOUR WIRE LOOPS ELECTRODES BROKE IN THE PT AND THE PIECES WERE RETRIEVED FROM THE PT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR CUTTING LOOP ELECTRODE - DEVICE #3 BIPOLAR CUTTING LOOP ELECTRODE KNS RICHARD WOLF MEDICAL INSTRUMENTS 4623.0223

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR