BEUDAMED
    FDA Adverse Event Other Summary report: N

    L11 LIGHT SOURCE

    MDR report key: 20557828 · Received October 28, 2024

    Report

    Report Number
    MW5161737
    Event Type
    Other
    Date Received
    October 28, 2024
    Date of Event
    October 10, 2024
    Report Date
    October 18, 2024
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INCORRECT END OF THE STRYKER LIGHT CABLE WAS ABLE TO BE PLUGGED INTO THE L11 STRYKER LIGHT SOURCE LIGHT WHEN THE POWER WAS ON THE CABLE ILLUMINATED WITHOUT THE SCOPE AND CAMERA ATTACHED. THIS CAUSED THE END ON THE STERILE FIELD TO BECOME HOT AND MELT THE STERILE DRAPE COVERING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725989 L11 LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other