BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 24671187 · Received March 23, 2026

    Report

    Report Number
    2955842-2026-17322
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 23, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LAMP ILLUMINATOR WAS REPLACED WITH NO ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE MALFUNCTION ALLEGATIONS. THE BULB FAILED TO LIGHT UP AFTER ONLY OVER 300 HOURS OF USE, WHICH IS FAR BELOW ITS DESIGNED SERVICE LIFE. THE HOSPITAL COMPLAINED ABOUT IT AS A QUALITY ISSUE. THE BULB LIGHT SOURCE DID NOT TURN ON. THE ISSUE WAS RESOLVED BY REPLACING THE BULB LIGHT SOURCE WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351873 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-16 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1