BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE PRELOADED SPHINCTEROTOME V

    MDR report key: 24581339 · Received March 12, 2026

    Report

    Report Number
    3008040402-2026-00098
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 1, 2026
    Manufacturer
    OLYMPUS VIETNAM CO. LTD.
    Product Code
    KNS
    UDI-DI
    04953170403187
    PMA / PMN Number
    K122505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS FOUND TO BE A DUPLICATE OF AN EVENT ALREADY REPORTED IN MFR#3008040402-2026-000943 FOR A1-PATIENT IDENTIFIER (B)(6). REFER TO THAT REPORT FOR ALL RELEVANT INFORMATION ON THE EVENT. 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 SINGLE-USE SPHINCTEROTOME'S WIRE BROKE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612295 SINGLE USE PRELOADED SPHINCTEROTOME V SINGLE USE PRELOADED SPHINCTEROTOME KNS OLYMPUS VIETNAM CO. LTD. KD-V631M-07202S 04953170403187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown