BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2764458 · Received September 28, 2012

    Report

    Report Number
    3005075853-2012-04437
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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). THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. IF THE DEVICE WAS ACTIVATED ACROSS A STAPLE LINE OR OTHER METAL IN THE JAWS, THIS WOULD CAUSE THE "REPOSITION AND REACTIVATE" YELLOW ALERT SCREEN TO APPEAR ON THE GENERATOR. THE "REPLACE INSTRUMENT" SCREEN IS DISPLAYED AFTER RECEIVING TWO YELLOW ALERT SCREEN MESSAGES OF "REPOSITION AND REACTIVATE" .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, SEVERAL TIMES DURING THE CASE REPOSITION ON TISSUE WAS DISPLAYED. IT WAS DIFFICULT TO DRIVE THE I-BLADE ACROSS THE THICK TISSUE EVEN THOUGH THE ENERGY BUTTON WAS FULLY DEPRESSED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL SUPER JAW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4AL3Y

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR