BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 21077545 · Received January 6, 2025

    Report

    Report Number
    2955842-2024-23987
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 11, 2024
    Report Date
    December 11, 2024
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A LAMP MODULE FAILURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE PERFORMED SERVICE TO RESOLVE THE ISSUE. CHECKED THE IMAGE QUALITY. FSE CHECKED THE LIGHT GUIDE CABLE AND REPLACED THE LAMP MODULE ALSO TESTED THE FUNCTION OF CAMERA AND PERFORMED SYSTEM TEST DRIVE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    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 UROLOGY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE DA VINCI SURGERY TECHNICAL ASSISTANCE TEAM (DVSTAT) AND REPORTED THAT THEY HAD A FAULT. THE CUSTOMER STATED THAT IMAGE WAS DARK ON BOTH THE SURGEON SIDE CONSOLE (SSC) AND THE VISION SIDE CART (VSC). THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO CHECK THE LIGHT CABLE AND ILLUMINATOR. THE CUSTOMER REPLIED THAT THEY FOUND THAT THE LIGHT CABLE CONNECTOR HAD BEEN OXIDIZED AND THE LAMP MODULE HAD BEEN USED FOR 933 HOURS. THE TSE SUGGESTED THE CUSTOMER TO REPLACE IT WITH A NEW LAMP MODULE AND THE CUSTOMER UNDERSTOOD. THE TSE RECORDED THE INFORMATION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE SURGEON AND PROCEDURE INFORMATION WAS UNKNOWN. THE CUSTOMER HAD REPLACED THE LAMP MODULE TO PROCEED WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE ISSUE AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE DA VINCI SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963090 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-16 N/A 00886874110874

    Patients

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