BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF 3000 GENERATOR

    MDR report key: 1071721 · Received July 9, 2008

    Report

    Report Number
    3005099803-2008-01100
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K981672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED, BUT THE EVAL HAS NOT BEEN COMPLETED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RF ABLATION PROCEDURE WAS PERFORMED ON A PATIENT'S LIVER. THE COMPLAINANT REPORTED THAT DURING THE PROCEDURE, THE POWER GENERATOR DISPLAYED AN "E7" ERROR CODE. IT WAS ALSO REPORTED THAT THE PHYSICIAN USED A SECOND RF 3000 GENERATOR TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PT COMPLICATION AND NO ADVERSE AFFECT ON THE PT AS A RESULT OF THE REPORTED GENERATOR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF 3000 GENERATOR GEI BOSTON SCIENTIFIC CORPORATION M001262210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK