BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC ADVANCED ENERGY, LLC

    MDR report key: 5381038 · Received January 20, 2016

    Report

    Report Number
    1226420-2016-00008
    Event Type
    Malfunction
    Date Received
    January 20, 2016
    Date of Event
    December 24, 2015
    Report Date
    December 24, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING ROUTINE PM TESTING, IT WAS IDENTIFIED THAT THE GENERATOR FAILED THE OUTPUT TESTING. THERE WAS REPORTEDLY HIGH OUTPUT ON LOW CUT SETTINGS 4 AND 5 WHEN TESTED WITH A BIOTEC RF 303 ESU ANALYZER AND A PLASMABLADE 3.0S DEVICE. ALL OTHER SETTINGS WERE WITHIN SPECIFICATIONS. CUSTOMER DID NOT WANT TO RE-TEST USING THE CORRECT EQUIPMENT (O-SCOPE AND CURRENT SENSING COILS) BECAUSE THE GENERATOR IS BEING SWAPPED OUT FOR ANOTHER GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40347 MEDTRONIC ADVANCED ENERGY, LLC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1