BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X1 TISSUE SEALER

    MDR report key: 15754787 · Received November 7, 2022

    Report

    Report Number
    MW5113151
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER SURGEON, ETHICON ENSEAL DEVICE PROVIDED BY PVH IS SUBSTANDARD, AND DOES NOT SEAL, CAUSING BLEEDING AND REQUEST TO OPEN A MONOPOLAR DEVICE TO FINISH PROCEDURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512788 ENSEAL X1 TISSUE SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLX137S X95G4D

    Patients

    Seq Age Sex Outcome Treatment
    1 Female