BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULIS ACCU2I PMTA APPLICATOR

    MDR report key: 2145157 · Received May 26, 2011

    Report

    Report Number
    9710493-2011-00008
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 16, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    NEY
    PMA / PMN Number
    K094021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THIS PROCEDURE, FORCE WAS REPEATEDLY PLACED ON THE APPLICATOR SHAFT BY RETRACTORS, ULTRASOUND PROBES AND THE LIVER TISSUE ITSELF IN USING THE APPLICATOR TO SERVE AS A RETRACTOR. THREE ABLATION PROCEDURES FOR 2 MINUTES EACH AT 180W WERE PERFORMED IN AND AROUND THE TARGET AREA. THE FOURTH ABLATION PROCEDURE WAS FOR 6 MINUTES AT 180W IN A DEEPER AREA. THIS WAS FOLLOWED FINALLY BY A FIFTH ABLATION PROCEDURE FOR 1:30 MINUTES AT 180W IN AN AREA SLIGHTLY PROXIMAL TO THE SITE OF THE 6 MINUTE ABLATION. AFTER 1:19 MINUTES THE TREATMENT FAILED AND AS THE APPLICATOR WAS DRAWN BACK OUT OF THE TISSUE IT WAS NOTED THAT THE CERAMIC TIP HAD BECOME DETACHED FROM THE SHAFT AND WAS STILL IN 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 3672

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR