BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 14619488 · Received June 7, 2022

    Report

    Report Number
    3005075853-2022-03663
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    April 14, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: X9420G. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 9/28/2022 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE HARH36 RECEIVED BELONG TO THIS COMPLAINT? I BELIEVE IT WAS A HARH36

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/11/2022 D4 BATCH #: X9420G 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 BLADE TIP DAMAGED, HOWEVER, THE BLADE WAS NOT CRACKED. IN ADDITION, THE DEVICE WAS RETURNED WITH THE TISSUE PAD DETACHED AND NOT RETURNED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND TESTED ON A (B)(6). THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. IF THE DEVICE IS ACTIVATED ACROSS A CLIP, STAPLE LINE, OR OTHER METAL IN THE JAWS, THE BLADE COULD GET DAMAGED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. ONCE MINOR BLADE DAMAGE HAS OCCURRED CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THESE ALERT SCREENS THAT CAN RESULT ARE 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. BASED ON THE CONDITION OF THE TISSUE PAD, A PROBABLE CAUSE OF THIS DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. KEEP THE CLAMP ARM OPEN WHEN BACK CUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. THE CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU, CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE. 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 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/29/2022. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: PROCEDURE PERFORMED WAS LAPAROSCOPIC HIGH ANTERIOR RESECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILST USING THE DEVICE, THE WHITE PLASTIC THAT IS EMBEDDED IN THE JAWS CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645326 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARH36 X9420G 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR AND HANDPIECE