BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB MONOPOLAR GRAY CORD

    MDR report key: 6656756 · Received June 20, 2017

    Report

    Report Number
    MW5070533
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    June 16, 2017
    Report Date
    June 16, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE ROBOTIC CASE WITH DR (B)(6) IN OPERATING ROOM 8, THE VALLEYLAB UNIT KSG 110 WAS NOT GIVING POWER TO ROBOTIC INSTRUMENT. THE GRAY MONOPOLAR CORD WAS CHECKED AT UNIT SITE AND ROBOTIC ARM. DR (B)(6) SAID IT WAS WORKING OK. ABOUT 10 MINUTES LATER, HE WAS HAVING THE SAME ISSUE OF NO POWER TO ROBOTIC INSTRUMENT. (B)(6) FIRST ASSISTANT BOTH LOOKED OVER AT THE VALLEYLAB AND SAW A SMALL FLAME THE SIZE OF A BIRTHDAY CANDLE AT THE PLUG SITE OF THE VALLEYLAB. SHE WAS ABLE TO EXTINGUISH THE FLAME WITH A WET TOWEL AND UNPLUGGED THE POWER CORD. THE PLUG / CORD CONNECTION BURNED THRU SEPARATED THE CORD IN TWO. A NEW MONOPOLAR CORD WAS OBTAINED AND VALLEYLAB UNIT TO FINISH THE SURGERY. DR (B)(6) WAS NOTIFIED OF INCIDENT AS IT HAPPENED REAL TIME. NO INJURY WAS NOTED AFTER INCIDENT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436144 VALLEYLAB MONOPOLAR GRAY CORD ELECTROSURGICAL, CUTTING, COAGULATION AND ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR