BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT GUIDE COMPATIBLE WITH DAVINCI 5

    MDR report key: 20578313 · Received October 30, 2024

    Report

    Report Number
    MW5161961
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 24, 2024
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Product Code
    EQH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LIGHT GUIDE CORD USED WITH THE DA VINCI 5 ROBOT WAS INTRAOPERATIVELY LAID ON THE STERILE DRAPE WITHOUT TURNING THE LIGHT SOURCE OFF. UNLIKE PREVIOUS VERSION OF LIKE EQUIPMENT, THE LIGHT SOURCE WAS NOT TURNED OFF REMOTELY THROUGH CAMERA. THE CONTINUED LIGHT LED TO A BURN THROUGH THE STERILE DRAPE AND 2 BLANKETS, LANDING ON THE SAFETY STRAP HOLDING THE PATIENT. THE PATIENT WAS NOT INJURED. THE ASSOCIATED LIGHT GUIDE CORD WAS ALSO FOUND TO BE CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960780 LIGHT GUIDE COMPATIBLE WITH DAVINCI 5 SOURCE, CARRIER, FIBEROPTIC LIGHT EQH SCHOELLY FIBEROPTIC, GMBH 05-00941-NIR (01)04250480109038(21)1092327(

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female