BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1003650 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00886
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 24, 2008
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE THAT THE HAND SWITCH DID NOT ACTIVATE. ANOTHER LIKE DEVICE WAS USED. 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 D9E763

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE