BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST SDE

    MDR report key: 1403321 · Received June 10, 2009

    Report

    Report Number
    1056436-2009-00034
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    May 20, 2009
    Report Date
    June 10, 2009
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED DUE TO THE PRODUCT NOT BEING RETURNED. A LOT NUMBER WAS PROVIDED THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. DUE TO THE UNAVAILABILITY OF THE DEVICE AND LOT NUMBER, THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THERE WAS A LUNG TUMOR 2CM ABLATION BY STARBURST SDE. TARGET TEMPERATURE IS 90 DEGREE 35W. DURING THE RFA PROCEDURE, THE TEMPERATURE IS RANGE FROM 45-50. OUTPUT ENERGY IS 1W-3W. EFFICIENCY IS 1. AND THEN WE CHANGE TO THE 2ND GENERATION GENERATOR, AFTER 5.2 MINUTES ABLATION, GENERATOR STOPPED. AFTER WE REOPEN IT, AND 0.8 MIN AFTER EACH TARGET TEMPERATURE, THE GENERATOR STOPPED AGAIN. DOCTOR ASKED TO DECREASE THE TARGET TEMPERATURE TO 80 DEGREE. AFTER 0.3 MIN ABLATION, THE GENERATOR STOPPED AGAIN. ABLATION CAN'T BE CONTINUED. AFTER COOL DOWN 0.5 MIN, EACH POINT OF TEMPERATURE IS AROUND 45-60 DEGREE. TOTAL TIME IS 25.2 MINS. THE TISSUE IS WITHOUT CHANGE UNDER CT. THE PATIENT HAS PNEUMOTHORAX BECAUSE THE OPERATION TIME IS LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST SDE RFA PROBE GEI ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other