BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULIS ACCU2I PMTA APPLICATOR

    MDR report key: 2484901 · Received March 8, 2012

    Report

    Report Number
    9710493-2011-00018
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    March 29, 2011
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    NEY
    PMA / PMN Number
    K094021
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PNTA APPLICATOR WAS INSERTED INTO THE PT AND THE SYSTEM WAS SET AT 180W FOR 3 MINUTES AND THE ABLATION WAS SUCCESSFULLY CARRIED OUT. THE PHYSICIAN FOLLOWED THIS WITH A TRACKED ABLATION OF 120W FOR 20 SECONDS TO RE-POSITION THE APPLICATOR. THIS WAS FOLLOWED BY A REPEAT ABLATION IN THE NEW POSITION AND ANOTHER TRACK ABLATION. WHEN THE SYSTEM WAS ACTIVATED FOR THE THIRD ABLATION AN ERROR MESSAGE WAS SHOWN ON THE GENERATOR SCREEN STATING "HIGH REFLECTIVE POWER" WHICH AUTOMATICALLY STOPPED THE SYSTEM. THE APPLICATOR WAS REMOVED FROM THE PT AND IT WAS NOTED THAT A PORTION OF THE CERAMIC TIP WAS MISSING AND HAD BEEN LEFT IN THE PT. THE TIP WAS SUBSEQUENTLY REMOVED FROM THE PT.

    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 3769

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR