BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2875400 · Received December 17, 2012

    Report

    Report Number
    3005075853-2012-05769
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PTC THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE PTC WAS LOOSE ON THE CONVEX PROXIMAL SIDE AND WAS OXIDIZED. 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) IT IS POSSIBLE THAT GOING OVER HARD OR TOUGH TISSUE OR GOING OVER CLIPS/STAPLES COULD HAVE CAUSED THE DAMAGE TO THE PTC; OR CAUSED BY OVER-USE OF THE DEVICE THE "REPOSITION AND REACTIVATE" OR "REPLACE INSTRUMENT" SCREENS WERE NOT DISPLAYED DURING ANY FUNCTIONAL TESTING. IT IS POSSIBLE THAT THE DAMAGED PTC CAUSED THE "REPOSITION JAWS AND REACTIVATE" AND "REPLACE INSTRUMENT" ALERT MESSAGES TO DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAVH PROCEDURE, THEY RECEIVED THE "REPOSITION JAWS ON TISSUE" MESSAGE SEVERAL TIMES AND THEY ALSO REPORTED SMELLING A BURNT PLASTIC LIKE SMELL. BECAUSE OF THIS, THE DECISION TO NOT USE THE DEVICE WAS MADE. ANOTHER DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE, AS THEY WENT TO A CLAMP, CUT AND TIE METHOD. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WILL BE RETURNING.

    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 J4AU9G

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR