BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9781806 · Received March 3, 2020

    Report

    Report Number
    1717344-2020-00222
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    April 6, 2017
    Report Date
    March 3, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: THERAPEUTIC OUTCOME OF CT-GUIDED RADIOFREQUENCY ABLATION IN PATIENTS WITH OSTEOID OSTEOMA SOURCE: SKELETAL RADIOL (2017) 46:949¿956 ONLINE PUBLICATION: 20 APRIL 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED TO ASSESS THE LONG-TERM OUTCOME OF COMPUTED TOMOGRAPHY-GUIDED RADIOFREQUENCY ABLATION (CT-GUIDED RFA) IN PATIENT WITH SUSPENDED OSTEOID OSTEOMA (OO). FROM 2008 TO 2015, 126 PATIENTS WERE TREATED BY CT-GUIDED RFA FOR OO PATIENTS WITH CLINICAL SUSPICION AND IMAGING DIAGNOSIS OF OSTEOID OSTEOMA WERE TREATED BY CT-GUIDED RFA USING THE SAME DEVICE WITH EITHER A 7- OR 10-MILLIMETERS (MM) ACTIVE TIP ELECTRODE. SPECIFIC PRECAUTIONS WERE APPLIED IN CASE OF ARTICULAR OR SPINAL OO. A 17-GAUGE RF CANNULA WITH A STRAIGHT COOLED TIP OF 7 MM OR 10 MM WAS USED IN ALL CASES. OUT OF 126 THAT WERE TREATED, 1 HAD MUSCULAR HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244722 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR