BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CUTTING LOOP ELECTRODE

    MDR report key: 2142572 · Received June 20, 2011

    Report

    Report Number
    1418479-2011-00013
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 20, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED TO RICHARD WOLF MEDICAL INSTRUMENTS AS OF THIS DATE. WE DO EXPECT THE DEVICE TO BE RETURNED AND WILL FOLLOW-UP TO FDA WITH AN EVALUATION. DEVICE AVAILABLE FOR EVALUATION: DEVICE IS AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION AS OF THIS DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TURB CYSTOSCOPY PROCEDURE, RIGHT RETROGRADE URETERAL PYELOGRAM, FOR TRANSURETHERAL SECTION OF BLADDER TUMOR, THE LOOP BROKE. THE PHYSICIAN FLUSHED THE BLADDER (IRRIGATION) AND RETRIEVED THE METAL LOOP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR CUTTING LOOP ELECTRODE BIPOLAR CUTTING LOOP ELECTRODE KNS RICHARD WOLF MEDICAL INSTRUMENTS 4622.251 850101

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR