BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM3-60

    MDR report key: 20278381 · Received September 23, 2024

    Report

    Report Number
    1722040-2024-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    UDI-DI
    10815288012983
    PMA / PMN Number
    K122383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE EM3-60 CABLE, WHICH IS CONNECTED TO THE ESU AND AEM MONITOR, BURNED IN THE OPERATING ROOM DURING SURGERY. THERE WERE NO INJURIES TO PATIENTS OR USERS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671833 EM3-60 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES GEI ENCISION INC. EM3-60 N/A 10815288012983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown