BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC PROBE

    MDR report key: 22095987 · Received May 28, 2025

    Report

    Report Number
    3002808148-2025-08400
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 25, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ITX
    PMA / PMN Number
    K982323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5, E1, H2, H3, H6, H11. CORRECTION: H6: DUPLICATE DETAILS UPDATED IN ERROR ON THE INITIAL MDR MEDWATCH. HEATH EFFECT-CLINICAL CODE (E2403). HEALTH EFFECT - IMPACT CODE (F26). MEDICAL DEVICE PROBLEM CODE: A040602, A040611 (X2), A090208, A0406. COMPONENT CODE: G04129, G07001. TYPE OF INVESTIGATION: B01. INVESTIGATION FINDINGS: C070601, C0706. INVESTIGATION CONCLUSIONS: D02. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMERS ALLEGATION WAS REPRODUCED. ADDITIONAL REPORTABLE MALFUNCTIONS WERE FOUND DURING THE INVESTIGATION WHICH NOTED THAT THE INSERTION SHEATH WAS TWISTED. THE INSERTION SHEATH WAS TWISTED (AROUND 70 CM FROM THE TIP). IT IS MOST LIKELY THAT THE REPORTED EVENT WAS DUE TO THE TWISTING OF THE INSERTION SHEATH WHICH INDICATES THAT STRESS WAS APPLIED TO THE TIP SHEATH DURING DRIVING. BASED ON HISTORICAL DATA, A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED/IDENTIFIED. 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 NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE ULTRASONIC PROBE WAS STRETCHED WHEN REMOVING THE UM-S20-17S. THE INTENDED PROCEDURE WAS COMPLETED WITH A OLYMPUS BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715552 ULTRASONIC PROBE ULTRASONIC PROBE ITX SHIRAKAWA OLYMPUS CO., LTD. UM-S20-17S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown