BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 4051507 · Received September 2, 2014

    Report

    Report Number
    3005075853-2014-06110
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 31, 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
    JA
    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. IN ADDITION, COATING MATERIAL OF THE HOUSING WAS FLAKING OFF. THE LOOSE PARTICLES ON THE SURFACE ARE ALUMINUM OXIDE FROM THE BASE MATERIAL. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE NOSE CONE WAS EXTREMELY CRACKED AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION: THE HANDPIECE WAS RECEIVED WITH THE NOSE CONE CRACKED AND THE MOUNT WAS NOTED TO BE LOOSE. IN ADDITION, COATING MATERIAL OF THE HOUSING WAS FLAKING OFF. THE LOOSE PARTICLES ON THE SURFACE ARE ALUMINUM OXIDE FROM THE BASE MATERIAL. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE NOSE CONE WAS EXTREMELY CRACKED AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE. 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 BEFORE A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, IT WAS FOUND THAT THERE WAS A CRACK IN THE NOSE CONE. THE NUMBER OF REMAINING USES WAS 50. THE DEVICE WAS STERILIZED WITH AUTOCLAVE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, IT WAS FOUND THAT THERE WAS A CRACK IN THE NOSE CONE. THE NUMBER OF REMAINING USES WAS 50. THE DEVICE WAS STERILIZED WITH AUTOCLAVE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533275 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND DISPOSABLE| GENERATOR AND DISPOSABLE