BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 21854798 · Received April 17, 2025

    Report

    Report Number
    2955842-2025-15527
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 24, 2025
    Report Date
    March 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH ILLUMINATOR ISSUES PRESENTING SYSTEM TRIGGERING ERROR 48245 "ILLUMINATOR LAMP FAILED TO IGNITE". PER REST OF THE IMAGES PROVIDED THE LAMP DOES NOT SHOW ANY PHYSICAL DAMAGED. PER IMAGE REVIEW, THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO AN OPEN CIRCUIT IN THE LAMP MODULE. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE MODULE TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE LAMP MODULE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE LAMP MODULE WAS PLACED ON AN IN-HOUSE SYSTEM. IT ATTACHED TO AND REMOVED FROM THE SYSTEM WITHOUT ANY ISSUES ON MULTIPLE ATTEMPTS. THE LAMP SUCCESSFULLY TURNED ON AND OFF WITHOUT ANY ISSUES ON MULTIPLE ATTEMPTS. THERE WERE NO ERRORS DISPLAYED. NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO MISUSE OF THE PRODUCT AND RECOGNITION ISSUES.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LIGHT BULB SUDDENLY FAILED TO WORK. IT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748048 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-15 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.