BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 14219117 · Received April 27, 2022

    Report

    Report Number
    1717344-2022-00496
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    November 21, 2021
    Report Date
    April 27, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: COMPARISON BETWEEN SUBTRACTION AND DYNAMIC MRI IN ASSESSING TREATMENT RESPONSE FOLLOWING RADIOFREQUENCY ABLATION IN PATIENTS WITH HE PATOCELLULAR CARCINOMA SOURCE: (B)(6) 2021, (B)(6) JOURNAL OF RADIOLOGY AND NUCLEAR MEDICINE GABR ET AL. (B)(6) J RADIOL NUCL MED (2021) 52:285 HTTPS://DOI.ORG/10.1186/(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, THE AIM OF THE PRESENT STUDY IS TO COMPARE THE ROLE OF SUBTRACTION MRI AND CONVENTIONAL DYNAMIC MRI IN THE ASSESSMENT OF TREATMENT RESPONSE FOLLOWING RFA IN PATIENTS WITH HCC. THIS PROSPECTIVE SINGLE INSTITUTION STUDY INCLUDED ALL CONSECUTIVE PATIENTS DIAGNOSED WITH HEPATOCELLULAR CARCINOMA (HCC) WHO WERE REFERRED TO THE RADIOLOGY DEPARTMENT FOR RFA FOLLOWED BY MRI ASSESSMENT FROM (B)(6) 2020. THE COOL-TIP RADIOFREQUENCY ABLATION SYSTEM E SERIES (COVIDIEN AG) WAS USED IN THE STUDY WHICH INCLUDED 48 PATIENTS WITH 62 HEPATIC FOCAL LESIONS. NO MAJOR COMPLICATIONS WERE RECORDED IN OUR STUDY EXCEPT FOR A SINGLE CASE OF OCCLUSION OF MAJOR PORTAL VEIN BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970202 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other