BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGY CAPITAL GENERATOR 11

    MDR report key: 3223516 · Received July 12, 2013

    Report

    Report Number
    3005075853-2013-03531
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS CONFIRMED THE GENERATOR ISSUE. THE POWER ENTRY MODULE WAS REPLACED AS IDENTIFIED IN THE INVESTIGATION TO ADDRESS THE GENERATOR ISSUE. ADDITIONALLY, PER SB12-008, THE GENERATOR WAS UPGRADED TO SOFTWARE VERSION AE. THE REPAIR AND TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL, BRINGING THE UNIT BACK TO FULL FUNCTIONALITY. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED BY THE APPLICABLE FRANCHISE CAPA COUNCIL ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS SENT TO THEM FOR REPAIR BECAUSE THERE IS A SHORT CIRCUIT IN THE UNIT. WHEN PERFORMING CLASS 1, CF MEASUREMENTS, WITH BIOTEK 601, PRO INSTRUMENT AT MED TECH DEPARTMENT, THEY FOUND THAT THE PROTECTIVE EARTH CONDUCTOR IS FAULTY, SPECIFICATIONS SHOULD BE 0.2 OHM, NOISES WERE HEARD DURING MEASUREMENT, AND 25 AMP WAS READ/USED BY SOME RELAYS AT POWER SUPPLY UNIT. LOOSE CONNECTIONS AT SOME OF THE PINS WERE FOUND. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323382 ENERGY CAPITAL GENERATOR 11 INSTRUMENT, ULTRASONIC SURGIICAL GEI ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1