BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 4093371 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06444
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K122797
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE JAWS LOCK ON THICK TISSUE WHEN FULLY ARTICULATED. THE JAW WAS OPENED WITH SOME EXTRA EFFORT. IT WAS DURING A TOTAL LAPAROSCOPIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570936 ENSEAL G2 ARTICULATING . GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR