BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE STENT INSERTION KIT V

    MDR report key: 25068031 · Received May 4, 2026

    Report

    Report Number
    9614641-2026-00467
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 4, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    QGE
    UDI-DI
    04953170347405
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    IT WAS REPORTED THAT THE MATERIAL GAVE WAY ON THE SINGLE USE STENT INSERTION KIT, EVEN THOUGH THE PLASTIC STENT HAD ALREADY PASSED THE DISTAL END OF THE DUODENOSCOPE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390923 SINGLE USE STENT INSERTION KIT V SINGLE USE STENT INSERTION KIT QGE AOMORI OLYMPUS CO., LTD. MAJ-1820 NI 04953170347405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COOK PLASTIC DRAINAGE TUBE.| PENTAX DUODENOSCOPE (ED34-I10T20).