BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 6012078 · Received October 7, 2016

    Report

    Report Number
    3005075853-2016-05809
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N90P8M. THE DEVICE WAS RECEIVED WITH NO APPARENT DAMAGE. THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED. 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). NO ISSUES WERE NOTED WITH OPENING AND CLOSING OF THE JAWS. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE SURGEON ATTEMPT TO MANUALLY OPEN THE JAWS WITH HIS FINGERS, IF NO: WAS THE DEVICE ON A VESSEL/ARTERY WHEN IT WOULD NOT OPEN:[(B)(6)] NO; DID THE SURGEON CONTINUE THE CASE WITH THIS SAME DEVICE:[(B)(6)] NO; IS THIS DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION:[(B)(6)] YES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON NOTED THAT THE BLADE FAILED TO OPEN. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664042 ENSEAL SUPER JAW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA N90Y2F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR