BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 24407888 · Received February 20, 2026

    Report

    Report Number
    2955842-2026-05304
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 2, 2024
    Report Date
    February 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    04250480109076
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SITE VISIT WAS PERFORMED, AND A FUNCTIONAL TEST PERFORMED OF THE NIR HANDHELD CAMERA SYSTEM AND LIGHT SOURCE. NO ISSUES WERE FOUND WITH OPERATION OF THE DEVICES. THE FSE VERIFIED THAT THE LIGHT SOURCE CAN BE TURNED ON AND OFF TO STANDBY MODE. THE FSE VERIFIED THAT THE HANDHELD CAMERA CAN CHANGE MODES WITH THE CONTROL BUTTONS. THE FSE WAS UNABLE TO PERFORM FULL SYSTEM VERIFICATION DUE TO THE SYSTEM BEING IN USE. THE FSE PROVIDED TECHNICAL DOCUMENTATION FOR USE OF LIGHT GUIDE AND REVIEWED THE WARNINGS/PRECAUTIONS FOR USE WITH THE ROBOTICS COORDINATOR. THE FSE SPECIFICALLY REVIEWED SECTION 3.1 PAGE 16 OF THE SCHOELLY LIGHT GUIDE INSTRUCTIONS FOR USE (IFU). THIS SECTION HAS PRECAUTIONS FOR LIGHT GUIDE USE REGARDING TEMPERATURE AFTER USE. THESE PRECAUTIONS FROM THE DOCUMENT WILL BE PRINTED AND DISPLAYED IN THE OPERATING ROOM (OR) FOR STAFF FUTURE USE. AFTER TESTING, THESE DEVICES WERE DEEMED SAFE FOR USE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED REVISION BAND TO DUODENAL SWITCH SURGICAL PROCEDURE, THE PATIENT SUSTAINED A BURN FROM THE SCHOELLY CAMERA. THE CAMERA WAS TURNED OFF AFTER USE AND LEFT PLUGGED IN WHEN STORED IN THE STERILE DRAPE SIDE POCKET. THE CAMERA TIP WAS STILL WARM AND THE HEAT MELTED THE STERILE DRAPE AND LEFT A BURN ON THE PATIENT THE SIZE OF A QUARTER. OINTMENT WAS ORDERED FOR THE BURN. THERE WAS NO ADDITIONAL TISSUE RESECTION OR FURTHER INTERVENTION REQUIRED. THERE WERE NO DA VINCI RELATED COMPLICATIONS OR ISSUES INTRAOPERATIVELY. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459259 NONE NIR HANDHELD CAMERA GCJ INTUITIVE SURGICAL, INC 470655-01 N/A 04250480109076

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.