BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2822641 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05050
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED 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 WITH THE KNIFE ADVANCING AND RETRACTING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TJAT DURING A LAVH PROCEDURE, THE UPPER JAW WOULD NOT OPEN AFTER IT WAS FIRED. THE JAW WAS MANUALLY OPENED AND A SECOND DEVICE WAS USED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    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 J4C24K

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| GENERATOR