BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 3811432 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03257
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE INSTRUMENT WAS RECEIVED INSERTED IN AN ETHICON TROCAR. THE TROCAR WAS REMOVED FROM THE INSTRUMENT AND THE INSTRUMENT WAS EVALUATED INDIVIDUALLY. THE INSTRUMENT WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE JAWS WERE SLIGHTLY DAMAGED AT THE JAW TO INSTRUMENT INTERFACE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DAMAGED NOT ALL TESTING WAS PERFORMED WITH THE GENERATOR. THE CONDITION OF THE JAW PREVENTED THE FUNCTIONALITY OF THE DEVICE. THE JAW WAS UNABLE TO FULLY CYCLE OPEN AND CLOSED. THE IDENTIFIED DAMAGE WAS THE LIKELY THE CAUSE FOR THE REPORTED DIFFICULTY IN REMOVING THE TROCAR. IT IS LIKELY THAT THE DAMAGE TO THE JAW AND I-BLADE WAS CAUSED BY NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT OR ATTEMPTING TO CUT THROUGH THICK DENSE TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO USE ON BLADDER FLAP. THE DEVICE WOULD NOT CLOSE AND COULD NOT BE REMOVED FROM TROCAR. THE SURGEON HAD TO REMOVE THE DEVICE AND TROCAR TOGETHER. THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290027 ENSEAL G2 ARTICULATING GEI ETHICON ENDO-SURGERY, LLC. UNK L4E35U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR