BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17698360 · Received September 7, 2023

    Report

    Report Number
    3005075853-2023-06423
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 2, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/27/2023. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE CLAMP ARM DAMAGED FROM THE INNER TUBE, BUT FIRMLY FIXED TO THE OUTER TUBE AT THE CLAMP ARM WELD.  THE BLADE TIP WAS NOT BROKEN OFF AS REPORTED BY THE CUSTOMER. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GEN11 AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. DUE TO THE DEVICE RETURNED CONDITION NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. POSSIBLE CAUSES OF THE CLAMP ARM DAMAGE ARE NOT CLOSING THE CLAMP WHEN SLIDING THE TORQUE WRENCH ON AND OFF;  NOT CLOSING THE CLAMP WHEN INTRODUCING OR REMOVING THROUGH THE TROCAR; OR POSSIBLE ENTANGLEMENT IN FIBROUS TISSUE. AS PART OF THE QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/7/2023. D4 BATCH #: A9C217. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCTRECTOMY THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037793 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. A9C217 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HANDPIECE AND GENERATOR.