BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 5903581 · Received August 25, 2016

    Report

    Report Number
    3005075853-2016-04803
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 25, 2016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # K92783. THE HANDPIECE WAS RECEIVED ATTACHED TO A HAR36 DEVICE. THE HANDPIECE WAS FORCIBLY REMOVED FROM THE DEVICE. THE NOSE CONE WAS 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. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. THE MOISTURE INDICATOR WAS POSITIVE. 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. DUE TO THE CRACKED NOSE CONE, MOISTURE ENTERED THE HAND PIECE MID HOUSING. 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 POSSIBLE THAT THE INGRESS OF MOISTURE AFFECTED HANDPIECE FUNCTIONALITY. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, IT WAS NOTICED AT THE TIME OF TESTING THAT THE DEVICE WAS NOT WORKING. THEN THEY WERE NOT ABLE TO GET THE HAND PIECE OFF THE DEVICE AND IT IS STILL STUCK ON. THE CASE WAS COMPLETED USING ANOTHER DEVICE AND HAND PIECE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555581 ULTRACISION HARMONIC SCALPEL HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1