BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULIS ACCU2I PMTA APPLICATOR

    MDR report key: 2246451 · Received August 19, 2011

    Report

    Report Number
    9710493-2011-00016
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 19, 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

    MICROSULIS MEDICAL HAVE SEEN TWO DISTINCT TYPES OF INCIDENT, NAMELY SHORT CIRCUIT-INDUCED TIP FRACTURES, CHARACTERIZED BY APPROXIMATELY TWO THIRDS OF THE TIP REMAINING IN THE TARGET TISSUE AND ONE THIRD ATTACHED TO THE APPLICATOR. (FAILURE PERCENTAGE IS (B)(4)). MECHANICALLY-INDUCED TIP DETACHMENT, CHARACTERIZED BY THE COMPLETE TIP BECOMING DETACHED FROM THE APPLICATOR. (FAILURE PERCENTAGE IS (B)(4)). THE FIRST TYPE IS THE OCCURRENCE AT THE CHURCHILL HOSPITAL, OXFORD, UK. CORRECTIVE ACTIONS FOR BOTH TYPES OF FAILURE HAVE BEEN IMPLEMENTED AS FOLLOWS: DURING OUR INVESTIGATION IT HAS BECOME APPARENT THAT THE EXISTING TIP DESIGN DID NOT ALWAYS EFFECTIVELY ISOLATE THE TWO CONDUCTORS OF THE COAXIAL CABLE. THE ISOLATION OF THE CONDUCTORS WAS CONTROLLED BY THE MANUFACTURING PROCESS AND AS A RESULT WAS SUBJECTED TO MANUFACTURING VARIATION. THEREFORE IN CONJUNCTION WITH THE TIP COMPONENT MANUFACTURER WE HAVE (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS BEING TREATED FOR 3 TUMORS IN THE LUNG. THE FIRST TUMOR WAS ABLATED AT 180 WATTS FOR 2 MINUTES 30 SECONDS, THE SECOND TUMOR WAS ABLATED AT 1800 WATTS FOR 3 MINUTES 30 SECONDS. THE APPLICATOR WAS RE-POSITIONED TO THIRD TUMOR AND UPON STARTING THE ABLATION A HIGH REFLECTIVE POWER OCCURRED. THE APPLICATOR WAS REMOVED AND THE TIP WAS MISSING. THE CERAMIC TIP WAS CONFIRMED TO HAVE REMAINED IN SITU ON THE PERIPHERY OF THE TUMOR BY CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCULIS ACCU2I PMTA APPLICATOR NEY - ELECTROSURGICAL COAGULATION DEVICE NEY MICROSULIS MEDICAL LTD. ACCU2I 4048

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR