BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3944610 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05085
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. IT WAS FOUND THAT THE DEVICE WAS SLOW TO RETURN TO A FULLY OPEN POSITION. THIS COULD HAVE IMPACTED THE OPENING AND CLOSING PERFORMANCE OF THE DEVICE. THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED AND THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED; AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). OPENING AND CLOSING OF THE JAWS MULTIPLE TIMES PRIOR TO USE WILL REDUCE OR ELIMINATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HYSTERECTOMY, THE JAW BECAME NOT TO OPEN AFTER SEALING. THE JAW WAS OPENED BY RETURNING THE HANDLE TO THE HOME POSITION BY HAND. THERE WAS NO DAMAGE TO THE TARGET TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422604 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4EK0U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE