BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17301057 · Received July 11, 2023

    Report

    Report Number
    3005075853-2023-04828
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 11, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/11/2023. D4 BATCH #: A9C29Z. 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: DID THE ACTIVE TITANIUM BLADE BREAK OFF? DID THE WHITE TISSUE PAD BREAK OFF? IS THE WHITE TISSUE PAD COMPLETELY MISSING FROM THE CLAMP ARM OF THE DEVICE? 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 AN UNKNOWN PROCEDURE THE DEVICE BROKE. CHANGE OF DEVICE. IT WAS DIFFICULT TO RECOVER THE MISSING PART. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687890 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARH36 A9C29Z 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HANDPIECE AND GENERATOR