BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080404 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00389
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ETHICON EDNO-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

    DATE SENT: 7/11/2008.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED WITH NO INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE NONE LFL ETHICON EDNO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1