BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1823812 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08221
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Report Date
    November 14, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. SIGMA, THE TISSUE PAD MELTED. NO FURTHER INFORMATION IS AVAILABLE. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4J59N

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR