BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 3823110 · Received May 21, 2014

    Report

    Report Number
    3005075853-2014-03388
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 21, 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. DEVICE WAS RECEIVED WITH TOP JAW SEPARATED FROM BOTTOM OF JAW AND RETURNED WITH THE DEVICE. THERE WAS EXTENSIVE DAMAGE (SEVERELY TWISTED) TO THE TOP JAW. PART OF THE HINGE/LOBE OF THE JAW WAS BROKEN OFF AND NOT INCLUDED. UNDER MAGNIFICATION, A SMALL DIVOT WAS NOTICED IN THE ELECTRODE. THERE WAS NO SKIVING (DAMAGE) OF THE SHAFT COVER MATERIAL. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SEPARATED JAW BUT MECHANICAL TESTING WAS DONE AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING FOR ROTATION AND ARTICULATION. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE JAWS COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE END EFFECTOR CAME OFF IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303776 ENSEAL G2 ARTICULATING GEI ETHICON ENDO-SURGERY, LLC. UNK L4E11J

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR