BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 22978730 · Received September 5, 2025

    Report

    Report Number
    2429304-2025-00241
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE REMOVAL OF THE SUBJECT DEVICE; THE PHYSICIAN UTILIZED A COOK FLEXOR PARALLEL ACCESS SHEATH. DUE TO ITS DESIGN, THE SHEATH CUT THE SUTURE AT THE HUB OF THE SUBJECT DEVICE. REPORTEDLY, THE PROCEDURE WAS PROLONGED BY AT LEAST OR GREATER THAN 30 MINUTES. AS A RESULT, THE PATIENT WAS MOVED TO THE OPERATING ROOM FOR SEDATION, AND THE DEVICE WAS SUCCESSFULLY REMOVED USING A CYSTOSCOPE SHEATH AND GRASPER. THERE WERE NO REPORTS OF FURTHER PATIENT IMPACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY OLYMPUS, BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265416 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 NI 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention