BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC PROBE

    MDR report key: 19607075 · Received June 25, 2024

    Report

    Report Number
    3002808148-2024-34289
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 26, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ITX
    UDI-DI
    04953170368479
    PMA / PMN Number
    K982323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1/FACILITY NAME: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE ULTRASOUND CATALYST WAS REDUCED DUE TO THE LEAKAGE OF LIQUID FROM THE TIP WHICH PREVENTED THE IMAGE FROM BEING DEPICTED PROPERLY AND LIQUID LEAKED FROM SCRATCHES ON THE TIP. THE CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD SOLUTION LEAKING OUT OF THE TIP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD SOLUTION LEAKING OUT OF THE TIP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480065 ULTRASONIC PROBE ULTRASONIC PROBE ITX SHIRAKAWA OLYMPUS CO., LTD. UM-S20-17S 04953170368479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown