BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EVIDENT GENERATOR

    MDR report key: 14085240 · Received April 12, 2022

    Report

    Report Number
    1717344-2022-00418
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 3, 2018
    Report Date
    April 12, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: COMBINED CHEMOEMBOLIZATION AND THERMAL ABLATION FOR THE TREATMENT OF METASTASES TO THE LIVER SOURCE: ABDOM RADIOL (2018) 43:2859¿2867. HTTPS://DOI.ORG/10. 1007/S00261-018-1536-X. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, THE PURPOSE OF THE STUDY WAS TO EVALUATE SAFETY, TIME TO RECURRENCE, AND OVERALL SURVIVAL IN PATIENTS WITH LIVER METASTASES, TREATED WITH TRANSARTERIAL CHEMOEMBOLIZATION (TACE) FOLLOWED BY ABLATION FROM (B)(6) 1998 TO (B)(6) 2015. THEY USED MULTIPLE ABLATION TECHNIQUES AND DEVICES WHEREIN ONE OF WHICH, INCLUDED RADIO FREQUENCY ABLATION SYSTEM WITH COOL-TIP. THERE WERE 42 PATIENTS TREATED FOR 44 LIVER METASTASES. COMPLICATIONS OCCURRED IN 19 PATIENTS (45%). THE MAJORITY OF PATIENTS EXPERIENCED COMPLICATIONS THAT RESULTED IN NO THERAPY OR NOMINAL THERAPY OF NO CONSEQUENCE. THESE COMPLICATIONS INCLUDED A BURN FROM THE ABLATION GROUNDING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146319 UNKNOWN EVIDENT GENERATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER UNKNOWN EVIDENT GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male