BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17645244 · Received August 29, 2023

    Report

    Report Number
    3005075853-2023-06233
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    May 16, 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 #: X9692A. 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 DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED AND WITH EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. DURING FUNCTIONAL TESTING ON GEN11, AN ALERT SCREEN WAS DISPLAYED. PROBABLY THE DEVICE STOPPED ACTIVATING AND DISPLAYED AN ALERT BECAUSE THE KNIFE IS DAMAGED. NO UNEXPECTED READY TO PRE RUN ISSUES WERE OBSERVED AT ANY TIME DURING THE TESTING. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES, OR CLIPS DURING THE PROCEDURE, OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS IN TURN CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THESE SCREEN ALERTS CAN BE SUCH AS, ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGED BLADE CAN RESULT IN A BROKEN BLADE. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/BATCH X9692A AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 PROSTATE PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. 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
    999996 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. X9692A 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR AND HANDPIECE