BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2719584 · Received August 29, 2012

    Report

    Report Number
    3005075853-2012-03969
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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). ADDITIONAL INFORMATION: JAW/SHAFT INTERFERENCE THE INSTRUMENT 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 TESTS, THERE WAS DIFFICULTY OPENING AND CLOSING THE JAWS. THE INSTRUMENT WAS DISASSEMBLED AND IT WAS FOUND THAT THERE WAS FRICTION BETWEEN THE UPPER JAW AND SHAFT ASSEMBLY. THIS WAS THE CAUSE FOR THE INABILITY TO OPEN AND CLOSE THE JAWS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS ISSUE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, TOWARDS THE END OF THE CASE, APPROXIMATELY TEN ACTIVATIONS THE JAWS WOULD NOT OPEN. THEY WOULD ONLY OPEN IF YOU MANUALLY OPENED THEM WITH YOUR FINGERS. PUSHING THE HANDLE FORWARD WOULD NOT OPEN THE JAWS. THE CASE WAS NEARLY COMPLETE BY THE TIME THE DEVICE MALFUNCTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR