BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 4173807 · Received October 15, 2014

    Report

    Report Number
    3005075853-2014-07102
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. NOSE CONE THE HANDPIECE WAS RECEIVED WITH THE NOSE CONE CRACKED AND THE MOUNT WAS NOTED TO BE LOOSE. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE NOSE CONE WAS EXTREMELY CRACKED AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE. WE ARE UNABLE TO INVESTIGATE THE "TIGHTEN ASSEMBLY" ISSUE DUE TO THE CONDITION OF THE DEVICE. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. THE MOISTURE INDICATOR WAS POSITIVE, THE ACOUSTIC ISOLATOR WAS TORN. THE TRANSDUCER ASSEMBLY WAS NOT HELD IN PLACE DUE TO THE CRACKED NOSE CONE, SO TORQUING ON THE DISPOSABLE RESULTED IN TWISTING ONLY THE HANDPIECE TRANSDUCER ASSEMBLY UNTIL THE INTERNAL WIRES GOT DISCONNECTED. 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. A POSSIBLE CAUSE OF THE NOSE CONE BEING CRACKED IS THE STERILIZATION METHOD DUE TO THE HEATING AND COOLING OF THE STERILIZATION CYCLES IS A STRESSOR. IT IS PROBABLE THAT THE INGRESS OF MOISTURE AFFECTED HANDPIECE FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICE GETS THE MESSAGE TIGHTEN THE ASSEMBLY, TIGHTER IT STILL NO CHANGES, TRIED ANOTHER HANDPIECE AND IT WORKED. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654425 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND DISPOSABLE