BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE

    MDR report key: 4792780 · Received May 19, 2015

    Report

    Report Number
    1418479-2015-00013
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    February 1, 2015
    Report Date
    April 23, 2015
    Manufacturer
    BOWA ELECTRONICS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AND INFORMATION NOT AVAILABLE. INFORMATION FROM FACILITY INDICATED DEVICE HAD REACHED ITS END OF LIFE OF TWO YEARS AFTER DEPLOYMENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SUBMITTED TO FACILITY, NO RESPONSE AS OF (B)(6) 2015. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE MANUFACTURER WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENT CORPORATION (RWMIC) SALES REPRESENTATIVE WAS NOTIFIED BY CUSTOMER INDICATED CABLE HAD FLAMED CAUSING A BURN MARK ON DRAPING. NO INJURY TO PATIENT OR STAFF WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324091 MONOPOLAR CABLE MONOPOLAR CABLE GEI BOWA ELECTRONICS 8106.033

    Patients

    Seq Age Sex Outcome Treatment
    1