BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERCP DISPOSABLE CAP

    MDR report key: 24742213 · Received March 31, 2026

    Report

    Report Number
    MW5186155
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 26, 2026
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO (2) ERCP DISPOSABLE CAPS WERE PLACED ON SCOPE TESTED AND CAME OFF. LUCKILY WE HAVE A VERY DILIGENT/EXPERIENCED TECH THAT WAS TESTING THEM. THESE WOULD HAVE FALLEN OFF IN THE PATIENT AND COULD HAVE GOTTEN INTO THE AIRWAY. THEY WERE DIFFERENT LOT NUMBERS. LOT H5Y25 AND LOT H5Y21 BOTH EXP: 2028-10-31. PT CODE: 4582. DEVICE CODES: 2907, 3015. REF REPORT: MW5186156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808391 ERCP DISPOSABLE CAP DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 H5Y25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other