BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9182241 · Received October 11, 2019

    Report

    Report Number
    1717344-2019-01307
    Event Type
    Injury
    Date Received
    October 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: FEASIBILITY AND OUTCOMES OF PERCUTANEOUS THERMAL ABLATION OF HEPATOCELLULAR CARCINOMA IN A TRANSPLANTED ALLOGRAFT SOURCE: BRIAN T. WELCH, 2017, ABDOMINAL RADIOLOGY, (2018) 43:1478¿1481, 21 SEPTEMBER 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI20 ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ON (B)(6) 2000 TO (B)(6) 2016, ELEVEN PATIENTS WITH HEPATIC ALLOGRAFT HCC UNDERWENT TWELVE PERCUTANEOUS THERMAL ABLATION PROCEDURES TO TREAT 16 LESIONS, ONE PATIENT (8%) WITH ROUX-EN-Y BILIARY RECONSTRUCTION DEVELOPED A MAJOR COMPLICATION WITH HEPATIC ABSCESS. GENERAL ANESTHESIA WAS USED DURING ALL CASES. HA ABLATIONS WERE PERFORMED WITH RADIOFREQUENCY ABLATION (RFA) OR MICROWAVE ABLATION (MWA) BASED ON OPERATOR SELECTION. IMPEDANCE-BASED INTERNALLY COOLED RFA (COOL-TIPTM, MEDTRONIC/COVIDIEN, DUBLIN IRELAND) OR 2450-KHZ MWA (CERTUS 140, NEUWAVE MEDICAL, MADISON WISCONSIN) SYSTEMS WERE USED IN ALL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973944 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention