BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2369052 · Received December 13, 2011

    Report

    Report Number
    3005075853-2011-05412
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 BLADE DID NOT RETURN AFTER THE HANDLE WAS DEPRESSED AND THE JAW DID NOT OPEN. THE JAWS WERE OPENED BY APPLYING AN OPENING FORCE ON THE HANDLE WITH TWO HANDS. THE KNIFE BLADE WAS BUCKLED WHICH RESULTED IN THE JAWS NOT OPENING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY, ADNEXECTOMY AND OMENTECTOMY PROCEDURE. AFTER A FEW TIME INSTRUMENT COULD NOT OPEN. OPENED MANUALLY. NO FURTHER INFORMATION IS AVAILABLE. A FOCUS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL SUPER JAW ENSEAL SUPER JAW GEI ETHICON ENDO-SURGERY, LLC. UNK H43T0U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE