BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

    MDR report key: 23332944 · Received October 19, 2025

    Report

    Report Number
    9610773-2025-06497
    Event Type
    Malfunction
    Date Received
    October 19, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 13, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4: LOT AND SERIAL NUMBER: THIS DEVICE IS LOT CODED. CORRECTION TO E1 EMAIL: THIS INFORMATION IS UNKNOWN. CORRECTION TO G4: 510K NUMBER IS K931995. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION WHERE THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. THE MOST LIKELY CAUSE IS SOME KIND OF EXCESSIVE FORCE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE RESECTION SHEATH EXHIBITED A CERAMIC IP MALFUNCTION. THE ISSUE OCCURRED DUIRNG REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297754 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS A42011A HIH OLYMPUS WINTER & IBE GMBH A42011A 173W-0081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown