BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM

    MDR report key: 1830322 · Received November 13, 2007

    Report

    Report Number
    1527736-2007-07622
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 24, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LADG, THE INSTRUMENT DID NOT COAGULATE BUT CUT AT ABNORMALLY HIGH TEMPERATURE. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GT2Z

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE