BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821274 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00372
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPANY REPRESENTATIVE WAS TO RETURN THE PRODUCT FOR EVALUATION. HOWEVER, AS OF (B)(4)2012, THE GENERATOR HAS NOT BEEN RETURNED. IF THE GENERATOR IS RETURNED THE EVALUATION WILL BE SUBMITTED ON A FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUT FUNCTION WORKED, BUT THE COAGULATION DIDN'T. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR I UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE