BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CUTTING ELECTRODE

    MDR report key: 2033394 · Received March 22, 2011

    Report

    Report Number
    1418479-2011-00005
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 22, 2010
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FAS
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010: RELEASED FOR DISTRIBUTION. RESULTS: THERE WAS NO AMPLE WIRE TO VERIFY SPECIFICATION. EVALUATION SUMMARY: (B)(4) - BIPOLAR CUTTING ELECTRODE, THREE PER BOX, STERILE. VISUAL INSPECTION CONFIRMED 90% OF THE WIRE LOOP MISSING FROM THE TIP. SMALL PIECES OF DISCOLORED INSULATION REMAINED AT THE BASE OF THE WIRE LOOP. THE INSULATION COVERING THE WIRE LOOP MELTED AND WAS MISSING. THIS IS THE FIRST BREAKAGE OF THIS ELECTRODE WITH LOT NUMBER 796101 OF WHICH 180 ELECTRODES WERE MANUFACTURED. CAUSE OF EVENT: UNUSUAL EVENT. THE SURGEON EXPERIENCED FIRST BREAKAGE WITH THIS TYPE OF ELECTRODE. CONDITION OF ELECTRODE PREVENTED ANY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTEROSCOPIC RESECTION POLYP AND ENDOMETRIAL ABLATION PROCEDURE, THE CUTTING LOOP BROKE. THE BROKEN PIECE WAS FLUSHED FROM THE UTERUS WITHOUT COMPLICATION TO THE PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR CUTTING ELECTRODE BIPOLAR CUTTING ELECTRODE FAS RICHARD WOLF MEDICAL INSTRUMENTS 4653.1313 796101

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR