BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXABLATE 2000

    MDR report key: 2291655 · Received May 31, 2011

    Report

    Report Number
    9615058-2009-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    November 20, 2009
    Report Date
    December 14, 2009
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    NRZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STOP SONICATION ASSEMBLY HAS BEEN AVAILABLE IN ITS CURRENT FORM ALMOST FROM THE BEGINNING OF THE USE OF THE EXABLATE AND THIS IS THE FIRST TIME IN PROBABLY AROUND 5000 TREATMENTS THAT SUCH A DEFECT HAS BEEN REPORTED. ALTHOUGH IN THIS CASE NO ADVERSE EVENT HAPPENED, SINCE THIS IS AN EMERGENCY SAFETY FEATURE, ITS FAILURE IS UNACCEPTABLE. COMPANY SENT AN APPLICATION NOTE TO ALL SITES. THE NOTE REQUIRES THE USERS TO PRESS THE STOP SONICATION BUTTON DURING POWER-UP FOR THE DAILY QUALITY ASSURANCE (DQA) TESTING. THIS ACTION SHOULD ONLY TAKE A FEW SECONDS AND SHOULD COMPLETELY PREVENT THE MALFUNCTION FROM HAPPENING DURING TREATMENT SINCE COMPANY CANNOT ENVISAGE ANY SCENARIO WHERE THE STOP BUTTON FAILS SPONTANEOUSLY DURING TREATMENT.

    Description of Event or Problem · 1

    STOP SONICATION ON CONSOLE FAILED TO OPERATE. IN THIS EVENT THE PHYSICIAN USED THE STOP SONICATION BUTTON TO LITERALLY STOP THE SONICATION AND NOT AS AN EMERGENCY BUTTON. THE EXECUTED SONICATION WAS SAFE THUS ABSOLUTELY NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXABLATE 2000 MRGFUS NRZ INSIGHTEC, LTD. EXABLATE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1