BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OR1 NEO IP, BAS

    MDR report key: 24471665 · Received February 27, 2026

    Report

    Report Number
    9610617-2026-00399
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 10, 2026
    Report Date
    February 27, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LMD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, A SERVICE TECH WILL BE SENT TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4). THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. THEREFORE, AN IMPORTER IS NOT REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, TC304 FAILED DURING PROCEDURE, IMAGE CUT IN AND OUT DUE TO THE PRONGS BEING DAMAGED. COULD NOT TAKE PICTURES DUE TO AIDA IN FIBERS NOT COMMUNICATING. USED ANOTHER ROOM, PROVIDED A SECONDARY MONITOR AND TOWER TO STAY IN THE SAME ROOM BUT SURGEON WANTED TO MOVE. SURGEON WAS ABLE TO COMPLETE PROCEDURE IN ANOTHER ROOM. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528019 OR1 NEO IP, BAS OR1 NEO IP, BAS LMD KARL STORZ SE & CO. KG WUIS2545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other