BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1112788 · Received August 12, 2008

    Report

    Report Number
    3005075853-2008-01135
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LAVH PROCEDURE, THE DEVICE ACTIVATED FOUR TIMES AND, THE SURGEON REALIZED THAT THE TIP HAD BROKEN OFF THE END OF THE DEVICE. NO METAL CONTACT OR THICK TISSUE. 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, LLC NA E4L38D

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE