BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OR1 NEO IP, ENH

    MDR report key: 24607703 · Received March 16, 2026

    Report

    Report Number
    9610617-2026-00552
    Event Type
    Injury
    Date Received
    March 16, 2026
    Report Date
    March 13, 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
    OK, 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

    IT WAS REPORTED THAT ALL DISPLAYS WENT BLACK AND TP FROZE DURING PROCEDURE. NO NEGATIVE IMPACT TO PROCEDURE OR PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667092 OR1 NEO IP, ENH OR1 NEO IP, ENH LMD KARL STORZ SE & CO. KG WUIS2546

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other