BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1032243 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02278
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 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

    DATE SENT: 4/18/08. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URINARY ORGAN PROCEDURE, THE HAND SWITCH DID NOT ACTIVATE. ONLY THE MAX BUTTON COULD BE USED ON ONE DEVICE AND THE OTHER DEVICE DID NOT ACTIVATE AT ALL. THE FOOT SWITCH WAS USED FOR BOTH DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JT44

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE