BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC PROBE

    MDR report key: 23657563 · Received November 26, 2025

    Report

    Report Number
    3002808148-2025-23523
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Report Date
    March 11, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ITX
    PMA / PMN Number
    K250762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO DOCUMENT THE FINDINGS AND CONCLUSIONS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED INFORMATION: D9 THE AFFECTED DEVICE WAS NOT RETURNED TO OLYMPUS AMERICA INC. FOR PHYSICAL INSPECTION. AS A RESULT, THE REPORTED MALFUNCTION ¿ SPECIFICALLY, RUPTURE OF THE OUTER SHEATH¿ COULD NOT BE CONFIRMED. BASED ON THE FINDINGS OF THE COMPLETED INVESTIGATION, AND IN THE ABSENCE OF THE RETURNED DEVICE FOR PHYSICAL EXAMINATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. NO CONCLUSIVE DETERMINATION REGARDING THE FAILURE MODE OR CONTRIBUTING FACTORS COULD BE MADE. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ULTRASONIC PROBE'S OUTER SHEATH WAS RUPTURED AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3459 ULTRASONIC PROBE ULTRASONIC PROBE ITX SHIRAKAWA OLYMPUS CO., LTD. UM-S20-17S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown