BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM3 MONOPOLAR ADAPTER, UNIVERSAL

    MDR report key: 12863169 · Received November 23, 2021

    Report

    Report Number
    1722040-2021-00003
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    UDI-DI
    10815288012983
    PMA / PMN Number
    K122383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE EM3-60 CABLE ADAPTER DISPLAYED BURNED OUTER INSULATION, INDICATING THE WIRE MAY HAVE BROKE AND BURNED THROUGH THE INSULATION. THE CABLE SPARKED IN THE OPERATING ROOM. THE LOCATION OF THE FAILURE OCCURED ON THE FOOT SWITCHING SIDE OF THE CABLE. THERE WAS NO INDICATION OF HARM TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764250 EM3 MONOPOLAR ADAPTER, UNIVERSAL ELECTROSURGICAL, CUTTING AND COAGULATION, DEVICE AND ACCESSORIES GEI ENCISION INC. EM3-60 10815288012983

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown