BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17641758 · Received August 29, 2023

    Report

    Report Number
    3005075853-2023-06194
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 29, 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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/29/2023. D4 BATCH #: UNKNOWN. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 LAP NEPHRECTOMY THE WHITE TISSUE PAD WAS COMPLETELY DETACHED. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. 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
    2209160 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. A9CD6X 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HANDPIECE AND GENERATOR.