BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2862521 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05519
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DEVICE A WAS RECEIVED WITH THE PTC SECURE IN THE TOP JAW BUT THE CONVEX PORTION WAS DEGRADED. 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 GENERATOR DID NOT DISPLAY ANY ALERT SCREENS. THE DAMAGED PTC CAN BE CAUSED BY OVER-USE OF THE DEVICE. DEVICE B 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, NO YELLOW ALERT SCREENS WERE DISPLAYED. THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY. DEVICE B J91P7K: MFG DATE 7-19-12, EXP DATE: 6-19-14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VAGINAL HYSTERECTOMY PROCEDURE, THE SURGEON HAD A DIFFICULT TIME ADVANCING THE BLADE ON DEVICE. THE DEVICE CAUSED REPOSITION JAWS AND REACTIVATE MESSAGES THEN A REPLACE INSTRUMENT MESSAGE. A SECOND DEVICE WAS USED IN WHICH THE BLADE COULD NOT BE ADVANCED. THE CASE WAS COMPLETED USING AN NSLG2S25. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. TWO DEVICES WILL BE RETURNED.

    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 J4C32Y

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR