BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 24129544 · Received January 21, 2026

    Report

    Report Number
    9610773-2026-00473
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Report Date
    January 21, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    501

    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 SHEATH DEVICE GAD A DAMAGED PORCELAIN TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194465 INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A HIH OLYMPUS WINTER & IBE GMBH A22040A 22424 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown