BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER CAMERA AND LIGHT CORD

    MDR report key: 21762601 · Received April 3, 2025

    Report

    Report Number
    MW5168550
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 1, 2025
    Manufacturer
    STRYKER COMMUNICATIONS, INC.
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FLEXIBLE SCOPE WAS SET UP, CAMERA WHITE BALANCED AND FOCUSED. THE IMAGE FROM THE SCOPE WAS BLURRY. WE BROUGHT IN A 2ND FLEXIBLE ENDOSCOPE AND WENT THROUGH THE SAME STEPS. WE HAD ANOTHER BLURRY IMAGE. WE SWITCHED THE CAMERAS OUT AND TRIED AGAIN, BUT WITH SAME IMAGE. WE CLEANED THE CAMERA HEAD, ENDOSCOPE HEAD AND TIPS VERY WELL AND TRIED ADJUSTING THE BRIGHTNESS SETTINGS TO GET A BETTER IMAGE. WE FINALLY GOT A SOMEWHAT DECENT IMAGE. THE PROCEDURE WAS STARTED. HOWEVER, SURGEON WAS UNABLE TO VISUALIZE THE COMPONENTS OF THE BRAIN TO BE ABLE TO SAFELY PERFORM A TUMOR BIOPSY. HE ABORTED THE BIOPSY PORTION OF THE PROCEDURE. REF REPORT: MW5168551.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323666 STRYKER CAMERA AND LIGHT CORD CAMERA, SURGICAL AND ACCESSORIES KQM STRYKER COMMUNICATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other