BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP SINGLE ELEC 20CM X 3CM KIT

    MDR report key: 2032355 · Received March 22, 2011

    Report

    Report Number
    1717344-2011-00212
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 24, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN RF ABLATION PROCEDURE, THE PATIENT COMPLAINED THAT THE SITE WHERE NEEDLE WAS PUNCTURED WAS HOT. A FEW DAYS POST OP, IT WAS CONFIRMED BY CT THAT TUMOR WAS FULLY ABLATED. ONE MONTH LATER, WHEN THE PATIENT SAW THE DOCTOR AS AN OUTPATIENT, A 3RD DEGREE BURN WAS NOTED AT THE NEEDLE-INSERTION SITE. INITIALLY, OINTMENT WAS GIVEN AND THE SIZE OF BURN BECAME SMALLER, BUT IT DID NOT HEAL COMPLETELY. THE PATIENT WAS HOSPITALIZED AND RECEIVED A SKIN GRAFT. AT THAT TIME, A LIGHT BLUE MATERIAL WAS FOUND INSIDE THE PATIENT AND WAS RETRIEVED. DURING THE RFA PROCEDURE, A TOSHIBA METAL ATTACHMENT WHICH IS ATTACHED TO THE ECHO PROBE WAS USED. IT IS BEING REPORTED THAT THE FOREIGN MATERIAL WAS FOUND ON THE ABDOMINAL WALL BUT NOT NEAR THE NEEDLE-INSERTION SITE. HOWEVER, IT IS POSSIBLE THAT THE MATERIAL MOVED WHEN THE SKIN GRAFT WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELEC 20CM X 3CM KIT RF ABLATION ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 173240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other