BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2638399 · Received July 3, 2012

    Report

    Report Number
    3005075853-2012-03064
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED IN GOOD CONDITION. 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) DURING FUNCTIONAL TESTING THE JAWS OPENED AND CLOSED AS INTENDED. THE DEVICE WAS DISASSEMBLED AND NO ISSUES WERE FOUND. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME 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

    ADDITIONAL INFORMATION: THE PROCEDURE CONTINUED AS A LAVH; NO UNINTENDED CHANGE IN PROCEDURE OR TO PATIENT'S POST-OP CARE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAVH PROCEDURE ON THE SECOND CARDINAL LIGAMENT, THE JAWS WERE STUCK ON TISSUE. THE SURGEON TRIED TO MOVE THE DEVICE BACK AND FORTH, AND THE DEVICE WOULD NOT MOVE. THE DEVICE HAD TO BE CUT OFF THE TISSUE WITH A KNIFE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL SUPER JAW ELECTRO-SURGICAL GEI ETHICON ENDO-SURGERY, LLC. UNK J4AL3W

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR