BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X1 TISSUE SEALER

    MDR report key: 15754769 · Received November 7, 2022

    Report

    Report Number
    MW5113150
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    ETHICON, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON USED PVH PROVIDED ETHICON ENSEAL, WHICH HE STATES IS NOT SEALING; CAUSING BLEEDING DUE TO THE PRODUCT STICKING TO PELVIC TISSUE. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512787 ENSEAL X1 TISSUE SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON, INC. NSLX137S X95G4D

    Patients

    Seq Age Sex Outcome Treatment
    1 Female