BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 25095796 · Received May 6, 2026

    Report

    Report Number
    9610617-2026-01004
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 4, 2026
    Report Date
    May 6, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    EYT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FRAGMENT OF THE DISTAL PART OF THE INNER SHEATH OF THE BIPOLAR RESECTOSCOPE FOUND IN THE BLADDER DURING CLOT EVACUATION. CURRENT PATIENT STATUS: NO CONSEQUENCES FOR THE PATIENT, BUT THE SITUATION COULD HAVE BEEN SERIOUS IF THE TEAM HAD NOT NOTICED THE PRESENCE OF A BROKEN FRAGMENT IN THE BLADDER. HOWEVER, EVEN WITHOUT ANY INJURY TO PATIENT REPORTED BUT THIS CASE WAS REPORT TO AUTHORITY BY USER AND THE SITUATION COULD HAVE BEEN SERIOUS IF THE TEAM HAD NOT NOTICED THE PRESENCE OF A BROKEN FRAGMENT IN THE BLADDER, THIS CASE IS REPORTABLE AS PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417898 UNKNOWN UNKNOWN EYT KARL STORZ SE & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1