BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHARMONIC ACE 36 CM

    MDR report key: 1210237 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02500
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 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
    UK
    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, TOWARDS THE END OF THE CASE, THE DOCTOR NOTICED THAT AS HE WAS PRESSING THE MAXIMUM BUTTON, THE BUTTON WAS GETTING STUCK AND ACTIVATING CONSTANTLY. IT WAS NOT REPORTED HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAHARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA E4KH2P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE