BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 3973413 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05412
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    June 30, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(40. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE HANDPIECE WAS RECEIVED WITH THE LOOSE MOUNT. BASED ON THE SERIAL NUMBER OF THE HANDPIECE, THE HANDPIECE IS 5 YEARS OLD AND HAS 139 USES. THE HANDPIECE WAS TESTED WITH A ACE36E INSTRUMENT AND RESULTED IN A RELAX PRESSURE ON BLADE ERROR. THE HANDPIECE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. MOISTURE EVIDENCE WAS FOUND, THE WASHERS WERE PRESENT AND THE ACOUSTIC ISOLATOR WAS TORN. THE HANDPIECE HAS A NUMBER OF SEALS TO PREVENT FLUIDS FROM ENTERING THE HOUSING. MOISTURE PRESENT 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 LOOSE MOUNT 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 LAPAROSCOPIC SIGMA PROCEDURE, GEN11 DISPLAY SHOWED ERROR CODE "PRESSURE TOO HIGH" BUT JAW WAS OPEN. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451060 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR