BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM W ERG HANDLE

    MDR report key: 1081895 · Received July 22, 2008

    Report

    Report Number
    3005075853-2008-00614
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 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, US
    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 LAP HYSTERECTOMY PROCEDURE, THE HAND ACTIVATION BUTTONS WOULD NOT WORK FOR THE FIRST TWO DEVICES. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH THE FOOT PEDAL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA E4L104

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR