BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 23803592 · Received December 15, 2025

    Report

    Report Number
    9610773-2025-08238
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 19, 2025
    Report Date
    January 29, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM CORRECTION TO SECTION H6- ADVERSE EVENT PROBLEM IN THE PREVIOUS INITIAL MDR REPORT SUBMITTED UNDER REPORT NO. 9610773-2025-08238-00. UPON REVIEW OF COMPLAINT RECORD, IN SECTION H6 FIELD, THE HEALTH EFFECT - CLINICAL CODE WAS INCORRECTLY NOTED AS E2401 - INSUFFICIENT INFORMATION AND THE HEALTH EFFECT - IMPACT CODE AS F24 - INSUFFICIENT INFORMATION. PLEASE REFER TO THE UPDATED SECTION H6- ADVERSE EVENT PROBLEM FOR THE UPDATED INFORMATION.

    Additional Manufacturer Narrative · 0

    E1 - COMPLETE INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: D2A - COMMON DEVICE NAME CORRECTED TO RESECTION SHEATH THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE CHIPPED TIP MALFUNCTION: DEGRADATION; COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE SUBJECT FLEX RESECTION SHEATH DEVICE HAD A CHIPPED TIP. THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720620 RESECTION SHEATH, 24 FR. RESECTION SHEATH HIH OLYMPUS WINTER & IBE GMBH A22041A 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown