BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, ELECTROSURGICAL, CUTTING & COAG & ACC.

    MDR report key: 3233261 · Received July 18, 2013

    Report

    Report Number
    1226348-2013-21454
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 1, 2013
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    MEDWATCH REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE SURGEON NOTED THAT THE MONOPOLAR CAUTERY SUDDENLY STOPPED WORKING. SURGEON NOTICED THAT THE MONOPOLAR CABLE BROKE INTO TWO PIECES AND NOTED A SMALL FIRE AT THE OF THE BROKEN PIECE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334486 DEVICE, ELECTROSURGICAL, CUTTING & COAG & ACC. GEI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR