BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS AMICA

    MDR report key: 10874839 · Received November 20, 2020

    Report

    Report Number
    10874839
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 9, 2020
    Manufacturer
    H.S. HOSPITAL SERVICE SPA
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AMICA MICROWAVE GENERATOR WAS USED AND SINGLE 16G APPLICATOR. 60W FOR 3 MINUTES WERE DELIVERED TO A RIGHT UPPER LOBE SUB CENTIMETER NODULE. CT IMAGES SHOWED A 6 CM BACKBURN ALONG THE ABLATION PROBE TO THE PLEURA. NOTE: "THE PROCEDURALIST TARGETED A 5 MM RUL SOLID NODULE. AT 60W FOR 3 MINUTES THE PHYSICIAN GOT A VERY LONG BACKBURN OF 6 CM (AND A BRONCHOPLEURAL FISTULA)." SOMEONE FROM THE HOSPITAL SPOKE WITH THE BOSTON SCIENTIFIC REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341275 HS AMICA ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI H.S. HOSPITAL SERVICE SPA AMICA-PROBE

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Other