BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2831811 · Received November 14, 2012

    Report

    Report Number
    3005075853-2012-05151
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE INSTRUMENT WAS RECEIVED IN GOOD CONDITION WITH THE JAW ATTACHED AND PROPERLY ALIGNED. THE DEVICES 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. THERE WAS NO DAMAGED TO THE JAW. 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). INFORMATION NOT ASKED FOR BUT UNKNOWN OR PROVIDED DURING INITIAL CONTACT. 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

    IT WAS REPORTED THAT DURING A ROBOTIC PROSTATE PROCEDURE, THE HINGE ON THE JAW BROKE AND/OR BECAME BENT AND COULD NOT BE USED. NO PIECES FELL INTO THE PATIENT. THE DEVICE WAS NOT FIRED OVER METAL. IT IS UNKNOWN WHAT LOCATION ON THE TISSUE THE DEVICE WAS BEING FIRED ACROSS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. NO OTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4C270

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR