BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 20281158 · Received September 23, 2024

    Report

    Report Number
    3011050570-2024-10357
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Report Date
    October 9, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FEO
    UDI-DI
    00821925043831
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION AND THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: E1 (TITLE UPDATED TO MS.), H6 (CHANGED MEDICAL DEVICE PROBLEM FROM ¿A191002¿ TO ¿A12¿ AND COMPONENT CODE FROM ¿G02004¿ TO ¿G04137¿) THE DEVICE WAS RETURNED TO OLYMPUS SERVICE CENTER FOR THE EVALUATION AND REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ROOT CAUSE BECAUSE MALFUNCTION WAS NOT REPRODUCED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO SHOCK AND WAS NOT WORKING AT ALL. THE ISSUE WAS FOUND DURING A DIAGNOSTIC DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO SHOCK AND WAS NOT WORKING AT ALL. THE ISSUE WAS FOUND DURING A DIAGNOSTIC DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503483 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI, INC. SPL-T 00821925043831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown