BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 23098309 · Received September 19, 2025

    Report

    Report Number
    3005075853-2025-07463
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/2/2025. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: CAN MORE INFORMATION BE PROVIDED ABOUT HOW THE HARH36 MALFUNCTION? AO LONGO DA CIRURGIA ELA PEDIA PARA REINICAR. O QUE ATRASOU MUITO A CIRURGIA. - DURING THE SURGERY, SHE ASKED TO RESTART, WHICH GREATLY DELAYED THE PROCEDURE. WERE THERE ANY ALERT SCREENS? PEDIR PARA REINICIAR - REQUEST TO RESTART WAS THE HARH36 WORKING AND THEN SUDDENLY STOPPED? AO LONGO DA CIRURGIA ELA PEDIA PARA REINICAR. O QUE ATRASOU MUITO A CIRURGIA. - DURING THE SURGERY, SHE ASKED TO RESTART, WHICH GREATLY DELAYED THE PROCEDURE. DID THE BLADE TIP BREAK OFF? NÃO - NO. DID THE WHITE TISSUE PAD BREAK OFF? NÃO - NO. IS THE WHITE TISSUE PAD COMPLETELY MISSING FROM THE CLAMP ARM OF THE DEVICE? NÃO - NO CAN THE GENERATOR LOG BE PULLED FROM THE GEN11 AND PROVIDED FOR ENGINEERING REVIEW? SIM - YES. CORRECTED DATA: H6 MEDICAL DEVICE PROBLEM CODE AND H6 TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/19/2025. CORRECTED DATA: H6 HEALTH EFFECT - IMPACT CODE AND H6 MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 9/19/2025 D4 BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS OBTAINED: ANYWAY, IT WAS JUST A TROUBLED AND STRESSFUL SITUATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT: CAN MORE INFORMATION BE PROVIDED ABOUT HOW THE HARH36 MALFUNCTION? WERE THERE ANY ALERT SCREENS? WAS THE HARH36 WORKING AND THEN SUDDENLY STOPPED? DID THE BLADE TIP BREAK OFF? DID THE WHITE TISSUE PAD BREAK OFF? IS THE WHITE TISSUE PAD COMPLETELY MISSING FROM THE CLAMP ARM OF THE DEVICE? CAN THE GENERATOR LOG BE PULLED FROM THE GEN11 AND PROVIDED FOR ENGINEERING REVIEW? AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE 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 COLECTOMY THE TWEEZERS HAD MALFUNCTION, DISARMING AND REQUESTING REBOOTING THROUGHOUT THE SURGERY. THERE WAS NO OTHER RESERVATION AVAILABLE, SO I USED WHAT WAS PROVIDED TO ME AT THE TIME. WHEN QUESTIONING WHETHER THERE WAS ANY DAMAGE TO THE PATIENT, THE DOCTOR REPLIED: ¿THE LONGER ANESTHESIA TIME AND THE TEAM¿S DIFFICULTY IN RESTORING THE PME TOOK THE PATIENT TO THE ICU AND INTUBATED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759976 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. Y70247 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other GENERATOR