BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2150730 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02312
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR FAILED TO DELIVER THE SET OUTPUT POWER. THE PROCEDURE WAS COMPLETED WITH THIS RF 3000 RADIOFREQUENCY GENERATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262200

    Patients

    Seq Age Sex Outcome Treatment
    1