BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR ELECTRODE, L-HOOK ELECTRODE

    MDR report key: 2619112 · Received June 11, 2012

    Report

    Report Number
    9611102-2012-00002
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 11, 2012
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY DID NOT RETURN THE DEVICE TO RICHARD WOLF FOR EVALUATION AS OF 06/01/2012, THEREFORE, A FULL INVESTIGATION COULD NOT BE COMPLETED. REPORTS ON THIS DEVICE WERE REVIEWED, THIS FACILITY HAS REPORTED NO PROBLEMS WITH THIS DEVICE IN THE LAST TEN YEARS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    HOSPITAL REPORTED: DURING A LAPAROSCOPIC PROCEDURE, THE ELECTRODE IN USE STOPPED WORKING. WHEN ELECTRODE WAS REMOVED, THE ISOLATION WAS FOUND TO BE DAMAGED AND A SLIGHT BURN MARK WAS OBSERVED ON TISSUE SURROUNDING THE TROCAR PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR ELECTRODE, L-HOOK ELECTRODE MONOPOLAR ELECTRODE IKD RICHARD WOLF GMBH 8384.423 1054590

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other