BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 4237867 · Received November 7, 2014

    Report

    Report Number
    3005075853-2014-07751
    Event Type
    Other
    Date Received
    November 7, 2014
    Date of Event
    July 15, 2014
    Report Date
    June 21, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HANDPIECE WAS RECEIVED WITH THE NOSE CONE CRACKED AND THE MOUNT WAS NOTED TO BE LOOSE. THE CONNECTOR WAS PLUGGED IN THE GENERATOR AND A ¿NO USES REMAINING- REPLACE HAND PIECE¿ ALERT SCREEN WAS DISPLAYED. FURTHER ANALYSIS CONFIRMED THAT THE HAND PIECE HAS ALREADY BEEN USED 95 TIMES. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE NOSE CONE WAS EXTREMELY CRACKED AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE. IT IS POSSIBLE THAT THE CRACKED NOSE CONE CAUSED THE REPORTED ASSEMBLY/DISASSEMBLY ISSUES. 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 AN UNKNOWN PROCEDURE, THE INSTRUMENT HAS BEEN JAMMED WITH THE HANDPIECE INSIDE. CUSTOMER CANNOT PROVIDE ANY MORE DETAILS ABOUT THE CIRCUMSTANCES IN WHICH THE ISSUE OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718769 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERATOR AND DISPOSABLE.| GENERATOR AND DISPOSABLE