BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 3833732 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03574
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 24, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED WITH THE UPPER JAW DETACHED AND NOT RETURNED. IN ADDITION, IT WAS NOTED THAT THERE WAS SKIVING OF THE HEAT SHRINK (SHAFT COVER) MATERIAL AND WITH ALL PRESENT. THE DEVICE WAS INSPECTED UNDER MAGNIFICATION AND NO ANOMALIES WERE NOTED WITH THE I-BLADE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DETACHED NOT ALL TESTING WAS PERFORMED WITH THE GENERATOR. 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. THE IFU WARNS "PRIOR TO INSERTING OR REMOVING THE DEVICE FROM THE TROCAR, ENSURE THAT THE DEVICE IS IN THE STRAIGHT, NON-ARTICULATED POSITION BY CONFIRMING THAT THE INDICATOR ARROW ON THE ARTICULATION WHEEL IS ALIGNED WITH THE TOP OF THE INSTRUMENT." THE IFU ALSO WARNS THE USER TO DISCONTINUE USE IF BLACK HEAT SHRINK COVERING IS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SUPRACERVICAL HYSTERECTOMY THE BLADE BROKE OFF OF THE NSLG2S35A. AN NSLG2C35A WAS USED IN PLACE OF THE FIRST DEVICE AND THE JAW WOULD NOT CLOSE. A THIRD UKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUECES REPORTED. IT WAS NOTED THAT WHEN THE GENERATOR WAS POWER OFF IT EMMITTED A CONTINUOUS BEEPING NOISE. THE NOISE DID ABATE AND THE GENERATOR WAS ALSO USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310100 ENSEAL G2 ARTICULATING GEI ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR