BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LED SAPHIRA, OPAL1 PDD

    MDR report key: 23577689 · Received November 17, 2025

    Report

    Report Number
    9610617-2025-02082
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 17, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    UDI-DI
    04048551441800
    PMA / PMN Number
    P050027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OUR US FACILITY AS DOCUMENTED IN SECTION D9 AND WILL LATER BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIGHT SOURCE KEPT LOSING ITS HIVE CONNECTION DURING A BLADDER CANCER SURGERY. THEY HAD A PROCEDURE WHERE THE LIGHT SOURCE WAS NOT SHOWING CONNECTION TO THE VIDEO SYSTEM AND CUSTOMER WAS UNABLE TO USE BLUE LIGHT FOR PROCEDURE. THEY DID NOT KNOW THIS WAS AN ISSUE UNTIL THEY WENT TO SWITCH CAMERA HEAD TO BLUE LIGHT. THIS IS A BIG ISSUE SINCE THERE IS NO WAY FOR CUSTOMER TO TROUBLESHOOT DURING A PROCEDURE NOR KNOW IF IT'S WORKING BEFORE PROCEDURE. THE LIGHT SOURCE SEEMS TO RANDOMLY LOSE ITS HIVE CONNECTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494351 POWER LED SAPHIRA, OPAL1 PDD POWER LED SAPHIRA, OPAL1 PDD OAY KARL STORZ SE & CO. KG TL410US 04048551441800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown