BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1822651 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07926
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 19, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SUPRACERVICAL HYSTERECTOMY, THE TISSUE PAD MELTED OFF OF THE CLAMP ARM. THE ACE36P WAS SWAPPED WITH ANOTHER ACE36P AND THE CASE WAS COMPLETED WITH 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 D4JJ15

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE