BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24126041 · Received January 20, 2026

    Report

    Report Number
    9610773-2026-00463
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 20, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761023658
    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

    FULL E1 - 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

    CORRECTION TO G4 - PMA/510(K) #: K931995. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION WHERE THE REPORTED FAILURE WAS REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. THE MOST LIKELY CAUSE IS SOME KIND OF EXCESSIVE FORCE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 CERAMIC TIP OF THE RESECTION SHEATH WAS LOOSE. THE EVENT WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF 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
    184393 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS A42011A HIH OLYMPUS WINTER & IBE GMBH A42011A 21809(KCTJT) 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown