BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENDO

    MDR report key: 25096426 · Received May 6, 2026

    Report

    Report Number
    1528319-2026-00045
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 6, 2026
    Manufacturer
    US ENDOSCOPY
    Product Code
    NWU
    UDI-DI
    00724995217402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED TO STERIS FOR EVALUATION. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE BIOPSY VALVE INCLUDED WITHIN THE DEFENDO SINGLE USE VALVE KIT WAS LEAKING WATER. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508811 DEFENDO BIOPSY VALVE NWU US ENDOSCOPY 00711901 (10)13417476 00724995217402

    Patients

    Seq Age Sex Outcome Treatment
    1