BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM ERG HANDLE

    MDR report key: 1082919 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00691
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS ACTIVATING INTERMITTENTLY DUE TO THE SWITCH BUTTON NOT WORKING. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC. NA E4L58C

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR