BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSONICS AUTOMATIC PULL BACK DEVICE

    MDR report key: 5835108 · Received July 29, 2016

    Report

    Report Number
    2939520-2016-00051
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 8, 2016
    Manufacturer
    ENDOSONICS CORP.
    Product Code
    ITX
    PMA / PMN Number
    K962293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND DURING A MAINTENANCE CHECK IN THE MANUFACTURER'S WAREHOUSE. THIS IS A REFURBISHED PRODUCT. THE ORIGINAL SERIAL # WAS (B)(4). THERE ARE NO LOT NUMBERS ASSOCIATED WITH THESE DEVICES. THERE IS NO EXPIRATION DATE ASSOCIATED WITH THIS DEVICE. THE FIELD SERVICE ENGINEER TESTED THE DEVICE. NO FACILITY INVOLVEMENT. THIS IS AN EMPLOYEE OF THE MANUFACTURER. THIS IS A REFURBISHED PRODUCT AND DATE NOTED IS DATE IT WAS REFURBISHED. THE ORIGINAL DEVICE MANUFACTURE DATE WAS 03/10/2005. THE DEVICE WILL BE TRANSFERRED TO THE REFURBISH DEPARTMENT TO EVALUATE FOR POSSIBLE REPAIR AND RE-CERTIFICATION. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    DURING A ROUTINE INSPECTION THE MANUFACTURER'S FIELD SERVICE ENGINEER FOUND THE DEVICE'S PULLBACK SPEED APPEARED FASTER THAN THE STANDARD SPEED SETTING. THE DEVICE WAS REQUESTED TO BE RETURNED FOR ANALYSIS. THE RETURNED DEVICE WAS INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. VISUAL INSPECTION DISCOVERED A MISSING BATTERY COVER AND THE BATTERY ITSELF. NO FURTHER DAMAGE WAS OBSERVED ON THE DEVICE. A KNOWN GOOD 9V BATTERY (MULTIMETER JMD # (B)(4)) WAS INSTALLED INTO THE DEVICE. THE DEVICE WAS FUNCTIONALLY TESTED FOR ITS PULLBACK SPEEDS. A FAILURE ANALYSIS (FA) LAB TIMER (JMD # (B)(4)) WAS USED DURING THE FUNCTIONAL TEST. TESTS AT BOTH SPEEDS WERE RUN FOR 120 SECONDS TIME DURATION; RESULTS NOTED BELOW. AT 0.5 MM/SEC: EXPECTED PULLBACK DISTANCE: 60 MM. MEASURED PULLBACK DISTANCE: 60 MM. AT 1.0 MM/SEC: EXPECTED PULLBACK DISTANCE: 120 MM. MEASURED PULLBACK DISTANCE: 130 MM. MANUFACTURING ENGINEERING WAS CONTACTED FOR FURTHER PRODUCT ANALYSIS AND COMPLETED THEIR INVESTIGATION ON 07-01-2016. ENGINEERING CONFIRMED THE SPEED ISSUE WITH THE DEVICE AND INDICATED THE CAUSE OF THE FASTER SPEED FAILURE WAS A FAULTY/WORN SPEED SWITCH ON THE UNIT. THIS EVENT IS BEING REPORTED BECAUSE A RATE FASTER THAN THE NOMINAL RATE HAS THE POTENTIAL TO RESULT IN INACCURATE IVUS-BASED LESION LENGTH MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484988 ENDOSONICS AUTOMATIC PULL BACK DEVICE TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX ENDOSONICS CORP. R-100

    Patients

    Seq Age Sex Outcome Treatment
    1