BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X - LARGE TISSUE SEALER

    MDR report key: 17967024 · Received October 18, 2023

    Report

    Report Number
    MW5147111
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 13, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENSEAL XLARGE JAW TISSUE SEALER REFERENCE NUMBER NSL X120L (LOT # "X7020N", DEVICE WAS GIVING ERROR TO "REPLACE INSTRUMENT ATTEMPTED TO REBOOT HARMONIC MACHINE BUT THE SAME ERROR MESSAGE CAME UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178410 ENSEAL X - LARGE TISSUE SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, INC. NSLX120L X7020N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown