BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 23388943 · Received October 27, 2025

    Report

    Report Number
    9610773-2025-06671
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 26, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 FIELD G4: 510K/PMA NUMBER IS UPDATED TO K931995. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. 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 THAT THE SUBJECT DEVICE CERAMIC TIP ON THE INNER SHEATH BROKE OFF. THE ISSUE WAS FOUND DURING A URETEROSCOPY CYSTOLITHOLAPAXY TRANSURETHRAL RESECTION OF THE PROSTATE THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    PROCEDURE COMPLETED WITH A SIMILAR DEVICE AND GREATER THAN 30-MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428703 RESECTION SHEATH, 24 FR. A22041A HIH OLYMPUS WINTER & IBE GMBH A22041A 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown