BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS AMICA

    MDR report key: 9659370 · Received February 3, 2020

    Report

    Report Number
    9659370
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 17, 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

    14GX15CM AMICA PROBE TIP MALFUNCTION FOLLOWING STANDARD SAFETY PROTOCOL RESULTING IN DISLODGEMENT OF THE PROBE TIP IN THE LIVER DURING ABLATION. THE ABLATION WAS ABORTED WITHIN 15 SECONDS OF THE FIRST ABLATION CYCLE. THE PROBE WAS REMOVED AND A NEW 14GX15CM AMICA PROBE WAS USED TO RE-ATTEMPT ABLATION. FOLLOWING STANDARD SAFETY PRACTICE THE NEW PROBE WAS INSERTED INTO THE AREA OF THE TUMOR. AFTER 1.5 MIN INTO THE ABLATION CYCLE, THE MACHINE ABRUPTLY CUT OFF DUE TO SIMILAR ISSUES AS THE FIRST INCIDENT. THE PROBE TIP WAS ALSO FOUND TO BE DISLODGED IN THE LIVER. THE LOT NUMBERS OF THESE TWO DEVICES WERE THE SAME. LOT# 37210. MANUFACTURER RESPONSE FOR APPARATUS FOR MICROWAVE ABLATION (AMICA) PROBE, AMICA PROBE (PER SITE REPORTER). HTTPS://WWW.HEALTHTRONICS.COM/SITES/DEFAULT/FILES/RESOURCES/AMICA%20INFORMATION%20SHEET.PDF THE RADIOLOGY SERVICE MADE THE LOCAL REPRESENTATIVE AWARE OF THE ISSUE. THIS PRODUCT IS DISTRIBUTED BY ENDOCARE, INC. - OTHERWISE, AMICA DOESN'T HAVE A UNITED STATES OFFICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122838 HS AMICA ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI H.S. HOSPITAL SERVICE SPA LOT# 37210

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Other