BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL-TIP RF ABLATION GENERATOR

    MDR report key: 22124292 · Received June 2, 2025

    Report

    Report Number
    1717344-2025-00707
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    September 29, 2024
    Report Date
    June 2, 2025
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN COOL-TI, UNKNOWN COOL-TIP RF ABLATION GENERATOR (SERIAL#: UNKNOWN) OUTCOMES AND COMPLICATIONS OF IMAGEGUIDED PERCUTANEOUS TUMOUR ABLATION FOR HEPATOCELLULAR CARCINOMA AT THE IRISH NATIONAL LIVER TRANSPLANT CENTRE / SYER REE TEE / CANADIAN ASSOCIATION OF RADIOLOGISTS JOURNAL 2025, VOL. 76(2) 333¿343/ DOI: 10.1177/08465371241286795 / JOURNALS.SAGEPUB.COM/HOME/CAJ MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY INCLUDING 118 CASES OF HEPATOCELLULAR CARCINOMA WHO UNDERWENT EITHER MICROWAVE ABLATION (MWA) OR RADIOFREQUENCY ABLATION (RFA) WAS COMPLETED BETWEEN 1ST JANUARY 2014 TO 31ST DECEMBER 2022. RFA WAS PERFORMED USING COOL-TIP RFA GENERATOR E SERIES. MWA WAS PERFORMED USING A COMPETITOR DEVICE. POTENTIAL DEVICE RELATED COMPLICATIONS INCLUDED LIVER ABSCESS REQUIRING DRAINAGE VIA INTERVENTIONAL RADIOLOGY. ONE CASE REQUIRED BOTH MWA AND RFA DUE TO A GENERATOR ERROR, HOWEVER, IT IS UNKNOWN WHICH PRODUCT GENERATOR MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391082 UNKNOWN COOL-TIP RF ABLATION GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL-TIP RF ABLATION GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention PLEASE SEE NOTE ON H11.