BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR1 NEO IP, ENH2 3.1.0.10

    MDR report key: 25318951 · Received May 28, 2026

    Report

    Report Number
    9610617-2026-01216
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LMD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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.

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, UPS POWERS DOWN BY ITSELF AND SUBSEQUENTLY POWERS DOWN ALL INTEGRATION. THE ONLY WAY TO RESOLVE THE ISSUE IS BY MANUALLY POWERING BACK ON THE UPS AND NEO-IP COMPONENTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160877 OR1 NEO IP, ENH2 3.1.0.10 OR1 NEO IP, ENH2 3.1.0.10 LMD KARL STORZ SE & CO. KG WUIS2548-02

    Patients

    Seq Age Sex Outcome Treatment
    1