BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL 45 CM SHAFT, CURVED JAW

    MDR report key: 11799605 · Received May 10, 2021

    Report

    Report Number
    3005075853-2021-02581
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036015499
    PMA / PMN Number
    K172580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/10/2021. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE NSLX145C DEVICE WAS RETURNED WITH THE DISTAL GUIDE WELD BROKEN. IN ADDITION, THE JAWS WERE NOT BROKEN OFF AS REPORTED. UPON VISUAL INSPECTION TO THE DEVICE IT WAS OBSERVED THAT THE GROUND WIRE WAS BROKEN AT THE DISTAL GUIDE AREA. THE DEVICE WAS TESTED ON THE GENERATOR, THIS RESULTED IN THE ¿CLOSE JAWS ON TISSUE AND REACTIVATE¿ ALERT SCREEN, THIS IS ADVISING THE GENERATOR CANNOT DELIVER ENERGY. THEN THE "REPLACE INSTRUMENT" SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "CLOSE JAWS ON TISSUE AND REACTIVATE" MESSAGE THREE TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACH ON HOW THE DISTAL GUIDE WELD GOT BROKEN. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U95645. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS MEANT BY "TIP BROKE OFF"? AT THE END OF THE DEVICE DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? YES. IS THE JAW DAMAGED BUT NOT BROKEN OFF? NO. IS THE TOP JAW LOOSE BUT NOT DETACHED? NO. IS THE TOP JAW PTC MATERIAL DAMAGED? NO. IS THE BLACK PTC IN THE UPPER JAW DETACHED? NO. IS THE TOP JAW BROKEN OFF THE OF THE DEVICE? YES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDRESECTIE THE DISTAL TIP BROKE OFF, SO IT COULD NOT CONTINUE BEING OPERATED WITH. THE DEVICE WAS USED TO DISSECT A LOT BUT THERE WAS STILL NORMAL AMOUNTS OF PRESSURE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698675 ENSEAL 45 CM SHAFT, CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLX145C 10705036015499

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR