BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 19586246 · Received June 21, 2024

    Report

    Report Number
    3011050570-2024-10185
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 23, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FEO
    UDI-DI
    00821925043831
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOTE CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR TRANSDUCER HAD NO POWER. THE ISSUE WAS FOUND DURING A THERAPEUTIC MINI PERCUTANEOUS NEPHROLITHOTOMY (PNL) LITHOTRIPSY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A LASER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR TRANSDUCER HAD NO POWER. THE ISSUE WAS FOUND DURING A THERAPEUTIC MINI PERCUTANEOUS NEPHROLITHOTOMY (PNL) LITHOTRIPSY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A LASER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218575 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI, INC. SPL-T 00821925043831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown