BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGY CAPITAL GENERATOR 11

    MDR report key: 3200932 · Received July 2, 2013

    Report

    Report Number
    3005075853-2013-03382
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS DOES NOT VERIFY THE ELECTRICAL SAFETY ISSUE. A BROKEN ADAPTER PLATE WAS REPLACED. THE TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. NO FURTHER INVESTIGATION BEYOND WHAT IS NOTED BELOW WILL BE CONDUCTED ON THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS DOES NOT VERIFY THE ELECTRICAL SAFETY ISSUE. THE TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HIS ANNUAL PM THE GENERATOR WAS NOT PASSING THE GROUND RESISTANCE TEST. NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301644 ENERGY CAPITAL GENERATOR 11 INSTRUMENT, ULTRASONIC SURGIICAL GEI ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1