BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL HAND PIECE

    MDR report key: 19843213 · Received July 26, 2024

    Report

    Report Number
    3005075853-2024-05475
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036002147
    PMA / PMN Number
    K002906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/26/2024. D4 BATCH #: K90321. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 REVEALED THAT THE DEVICE WAS RECEIVED WITH NO APPARENT DAMAGE. IT WAS EVALUATED WITH A TEST INSTRUMENT AND A ¿NO USES REMAINING- REPLACE HAND PIECE¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR WHEN IT WAS CONNECTED TO PERFORM THE FUNCTIONAL TESTING. FURTHER ANALYSIS CONFIRMED THAT THE HAND PIECE HAS ALREADY BEEN USED 95 TIMES. THE HANDPIECE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS,. THE MOISTURE INDICATOR WAS POSITIVE. THE HANDPIECE HAS A NUMBER OF SEALS TO PREVENT FLUIDS FROM ENTERING THE HOUSING. "POSITIVE MOISTURE INDICATOR¿ DESCRIBES A CONDITION WHERE WATER ENTERS THE HANDPIECE CAVITY DURING THE STEAM STERILIZATION PROCESS. THE PRIMARY PATH OF INGRESS IS THE DISTAL SEAL, THIS MAY BE CAUSED BY A REDUCTION OF THE COMPRESSIVE FORCE ON THE DISTAL SEAL. HOWEVER, NO DEFINITIVE ROOT CAUSE COULD BE DRAWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF THE QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE HANDPIECE IS A RE-USEABLE INSTRUMENT WITH A LIMITED SERVICE LIFE. THE DEVICE IS PROGRAMMED WITH A COUNTER TO LIMIT THE SERVICE LIFE TO 95 PROCEDURES. THE ¿NO USES REMAINING- REPLACE HAND PIECE¿ ALERT SCREEN ADVISES THAT THE HAND PIECE HAS REACHED THE END OF LIFE. THIS IS NOT RELATED TO A FUNCTIONAL FAILURE. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT. IT IS PROBABLE THAT THE INGRESS OF MOISTURE AFFECTED HANDPIECE FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HAS NO OR WEAK POWER. CASE WAS STARTED AND COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586410 HARMONIC SCALPEL HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036002147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERATOR