BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL HAND PIECE

    MDR report key: 8391202 · Received March 5, 2019

    Report

    Report Number
    3005075853-2019-17019
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    December 19, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036002147
    PMA / PMN Number
    K002906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # P92004. INVESTIGATION SUMMARY: 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 BEING EXTREMELY CRACKED (AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE). THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS AND THE MOISTURE INDICATOR WAS FOUND TO BE 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 BECAME DISCONNECTED. DUE TO THE CRACKED NOSE CONE, MOISTURE ENTERED THE HAND PIECE MID-HOUSING. IT IS POSSIBLE THAT THE CONDITION OF THE NOSE CONE CONTRIBUTED TO THE ASSEMBLY ISSUE WHEN TRYING TO ATTACH THE INSTRUMENT TO THE HANDPIECE. ANALYSIS WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE THAT LEAD TO CRACK IN THE HANDPIECE NOSE CONE. IT IS POSSIBLE THAT THE INGRESS OF MOISTURE AFFECTED HANDPIECE FUNCTIONALITY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE HP054 WAS NOT ACTIVATED. THE NUMBER OF REMAINING USES OF HP054 WAS UNKNOWN. MOREOVER, THE DEVICE COULD NOT BE REMOVED FROM THE HP054. ANOTHER HP054 WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186266 HARMONIC SCALPEL HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036002147

    Patients

    Seq Age Sex Outcome Treatment
    1