BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080407 · Received July 24, 2008

    Report

    Report Number
    3005075853-2005-00391
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/11/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ERROR 3 WAS DISPLAYED. THE CUSTOMER USED A COMPETITOR'S DEVICE TO PROCEED WITH THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR