BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST 15CM MODEL 75 JAPAN

    MDR report key: 1300324 · Received January 29, 2009

    Report

    Report Number
    1056436-2009-00009
    Event Type
    Injury
    Date Received
    January 29, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 29, 2009
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SKIN BURNED BY USING HAND-PIECE, STARBURST 15CM 700-101492J DURING AN OPERATION. THE PT'S SKIN WAS BURNED ABOUT 1CM. THE OPERATION WAS NORMAL AS USUAL, HOWEVER THE DOCTOR FELT SPEED OF INCREASING TEMPTER WAS A LITTLE BIT SLOW. DOCTOR USUALLY SET THE TEMPTER 90W BUT ROSE TO 110W BECAUSE IMPEDANCE WAS LOW AS 40. DOCTOR STARTED TO OPEN TINES FROM 2CM AND HE REALIZED HE REACHED TO THE TARGET TEMPTER ABOUT 3MIN AND AT THE SAME TIME, THE TEMPTER OF THE PT'S SKIN AROUND THE AREA RAISED. THEY USED ICE AND TRIED TO DECREASE THE TEMPTER OF THE SKIN, HOWEVER, AS A RESULT THE PT HAD ABOUT 1CM SKIN BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST 15CM MODEL 75 JAPAN RFA PROBE GEI ANGIODYNAMICS, INC. NA 28435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other