BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULIS ACCU2I PMTA APPLICATOR

    MDR report key: 2476101 · Received April 1, 2011

    Report

    Report Number
    9710493-2011-00017
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    August 30, 2010
    Report Date
    March 29, 2011
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    NEY
    PMA / PMN Number
    K094021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE X-RAYED.

    Description of Event or Problem · 1

    THE PMTA APPLICATOR WAS PLACED PERCUTANEOUSLY INTO THE TARGET LIVER TISSUE. THE ABLATION PROCEDURE PARAMETERS WERE SET AT 160WATTS FOR 6 MINS. THE PROCEDURE COMMENCED AS EXPECTED FOR A DURATION OF 4 MINS AT WHICH TIME THE SYSTEM ALARMED AND THE PROCEDURE TERMINATED. WHEN THE APPLICATOR WAS REMOVED FROM THE TARGET TISSUE, APPROX TWO THIRDS OF THE CERAMIC TIP OF THE APPLICATOR WAS MISSING. SUBSEQUENT CT IMAGING INDICATED THE PRESENCE OF THE DETACHED CERAMIC TIP WITHIN THE TARGET TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCULIS ACCU2I PMTA APPLICATOR NEY - ELECTROSURGICAL CUTTING COAGULATION NEY MICROSULIS MEDICAL LTD. ACCU2I WOAB 3081

    Patients

    Seq Age Sex Outcome Treatment
    1