BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGY CAPITAL GENERATOR 11

    MDR report key: 2221425 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03471
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BASED ON THE NEW INFORMATION RECEIVED, THIS COMPLAINT IS NOT REPORTAB.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(6).

    Description of Event or Problem · 1

    CORRECTED EVENT INFORMATION RECEIVED: WHILST CARRYING OUT THE SAFETY CHECK I SAW A FLASH IN THE FRONT PANEL DISPLAY COVER AND A SMELL OF BURNING AND IMMEDIATELY CANCELLED THE TESTING. UNFORTUNATELY I DON'T KNOW WHAT TEST WAS BEING CARRIED OUT AT THE TIME. SO IT DIDN'T ACTUALLY FAIL THE SAFETY CHECK BUT FAILED DURING THE TEST BASED ON THE NEW INFORMATION RECEIVED, THIS COMPLAINT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GENERATOR FAILED THE SAFETY TEST PRIOR TO ENTERING SERVICE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGY CAPITAL GENERATOR 11 ENERGY CAPITAL GENERATOR 11 LFL ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1