BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 3961586 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05255
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 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
    FL, 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 RECEIVED THE UPPER JAW BENT AT THE PROXIMAL SIDE BUT NOT DETACHED. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS ARE FULLY CLOSED, RESULTING IN AN ALERT SCREEN "REPOSITION JAWS AND REACTIVE", THIS IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS), THE "REPLACE INSTRUMENT" ALERT SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" ALERT SCREEN TWICE. 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 THE JAWS BECAME DISLODGED OUTSIDE OF THE PATIENT LAP SUPRACERVICAL HYSTERECTOMY. CUSTOMER TRIED A SECOND DEVICE BUT REPORTED HAVING PROBLEMS FIRING THE DEVICE. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439276 ENSEAL G2 ARTICULATING GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR