BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE, HF, UNIPOLAR

    MDR report key: 3733284 · Received March 28, 2014

    Report

    Report Number
    1418479-2014-00013
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    December 20, 2013
    Report Date
    February 27, 2014
    Manufacturer
    BOWA ELECTRONIC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RWMIC CONTACTED HOSPITAL AND REQUESTED ADDITIONAL INFO AND EITHER DEVICE OR PHOTO OF DEVICE. NO RESPONSE TO REQUESTS OF (B)(4) 2014. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE FDA AND (B)(4) WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MAUDE REPORT ON (B)(6) 2014, INDICATING: PROCEDURE: LAPAROSCOPIC HYSTERECTOMY (ROBOT ASSISTED). DURING PROCEDURE A "BURNING SMELL AND SPARKS" WERE NOTED COMING FROM THE MONOPOLAR CABLE. PROCEDURE WAS STOPPED, MONOPOLAR CABLE REPLACED AND PROCEDURE COMPLETED WITH NO ADDITIONAL ISSUES. NO BURNS OR INJURIES WERE REPORTED. FACILITY NOTED DAMAGE TO CORD AT THE STRESS POINT ON THE PROXIMAL END BY THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185088 CABLE, HF, UNIPOLAR MONOPOLAR CABLE GEI BOWA ELECTRONIC 8106.132

    Patients

    Seq Age Sex Outcome Treatment
    1