BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 25257232 · Received May 22, 2026

    Report

    Report Number
    9614641-2026-00534
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 22, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K250296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 THE DISPOSABLE DISTAL ATTACHMENT WAS UNINTENTIONALLY LEFT ON A SCOPE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506413 DISPOSABLE DISTAL ATTACHMENT DISPOSABLE DISTAL ATTACHMENT FDS AOMORI OLYMPUS CO., LTD. D-201-10704 6K7052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown