BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGY CAPITAL GENERATOR 11

    MDR report key: 3820558 · Received May 20, 2014

    Report

    Report Number
    3005075853-2014-03365
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    January 21, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DID NOT CONFIRM THE REPORTED ISSUE OF THE COOLING FAN ERROR SCREEN, BUT AN EARTH GROUND NUT WAS FOUND TO BE MISSING AND WAS REPLACED. ADDITIONALLY, PER SERVICE BULLETIN SB11-008, THE EPAC TOP (CONDOR), CABLE ASSY, ENCL./HEATSINK FAN TO MAIN, AND EPAC BOTTOM AND TAPE SUB-ASSEMBLY WERE REPLACED AND PER SERVICE BULLETIN SB13-002, THE GENERATOR WAS UPGRADED TO SOFTWARE VERSION 2013_1. THIS WAS UNRELATED TO THE REPORTED ISSUE. AS THE GENERATOR CAN BE SERVICED/REPAIRED BY A HOSPITAL BIOMED, NO CONCLUSION COULD BE REACHED AS TO WHY THE EARTH GROUND NUT WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE INTERNATIONAL SERVICE CENTER THAT THE GENERATOR WAS SENT TO THEM FOR REPAIR BECAUSE THERE WAS A COOLING FAN ERROR. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298902 ENERGY CAPITAL GENERATOR 11 INSTRUMENT, ULTRASONIC SURGIICAL GEI ETHICON ENDO-SURGERY, LLC. G11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1