BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 2850902 · Received November 29, 2012

    Report

    Report Number
    3005075853-2012-05384
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE HAND PIECE WAS RECEIVED IN GOOD PHYSICAL CONDITION. INITIAL VISUAL INSPECTION REVEALED THAT THE INSULATION CABLE WAS REFURBISHED. THE HANDPIECE WAS TESTED FOR FUNCTIONALITY, THE SERIAL NUMBER STORED IN THE INTERNAL MEMORY DID NOT MATCH THE SERIAL NUMBER MARKED IN THE CONNECTOR. HOWEVER THE DEVICE WORKED AS EXPECTED DURING TESTING. WHEN THE HAND PIECE WAS DISASSEMBLED, EVIDENCE OF REFURBISHED ACTIVITIES AND COMPONENT REPLACEMENT WAS NOTED. INTERNAL COMPONENTS WERE DIFFERENT FROM THE ONES USED AT THE CURRENT EES MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETUREND WITHOUT ANY DOCUMENTATION NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1