BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFA ELEC SINGLE 20 CM X 3 CM

    MDR report key: 5042239 · Received August 31, 2015

    Report

    Report Number
    1717344-2015-00606
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 6, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT 10/12/2015. EVALUATION OF THE INCIDENT ELECTRODE FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT RECEIVED A 3RD DEGREE BURN AT THE NEEDLE INSERTION POINT (S2) DURING THE ABLATION PROCEDURE. A HAKKO RFA NSP 14G T-U0015-MM GUIDING NEEDLE WAS ALSO USED. OINTMENT WAS APPLIED TO THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575056 RFA ELEC SINGLE 20 CM X 3 CM RFA ELECTRODE GEI COVIDIEN LP RFA2030 43520268X

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other