BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HANDPIECE

    MDR report key: 1831445 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08551
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, RECEIVED AN ERROR CODE 4. AFTER THE PROCEDURE WAS OVER, THE HANDPIECE WAS STILL TOO HOT TO HOLD. THE CASE WAS COMPLETED WITH A SECOND HANDPIECE WITH NOT PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HANDPIECE LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR