BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP RF SING, 20CMX2CM KIT

    MDR report key: 2190336 · Received July 20, 2011

    Report

    Report Number
    1717344-2011-00575
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE KEEPING THE PT'S UPPER BODY ERECT, THE METAL GUIDING NEEDLE WAS INSERTED INTO S4 AND THEN THE ACT2020 ELECTRODE WAS INSERTED THROUGH IT. THE ABLATION WAS PERFORMED WITHOUT INCIDENT. THEN THE PT WAS LAID FLAT AND THE GUIDING NEEDLE AND ACT2020 WERE INSERTED INTO S5 FOR A SECOND ABLATION. DURING THE SECOND ABLATION, THE IMPEDANCE DID NOT REACH 80 OHMS AND NO PULSES OCCURRED. THE DOCTOR STOPPED THE ABLATION AND FOUND THAT THE PT HAD A 3RD DEGREE BURN INJURY AT THE NEEDLE INSERTION SITE. THE SKIN SURFACE WAS DENUDED AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SING, 20CMX2CM KIT ABLATION ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 191244

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other