BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24695758 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18659
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    July 29, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 USED LOCALHOST:8649 TO PROGRAM THE TOWER FROM GOLDEN IMAGE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED INCISIONAL HERNIA ETEP SURGICAL PROCEDURE, THE OPERATING ROOM EXPERIENCED A POWER SURGE DURING SETUP, RESULTING IN A NON-RECOVERABLE ERROR 40096 ON THE SYSTEM. DESPITE SEVERAL RESTARTS AND A HARD POWER CYCLE, THE ISSUE PERSISTED. LOGS INDICATED ERROR 311 RELATED TO A GOLDEN IMAGE ON THE MSC IN THE TOWER. THE CUSTOMER DECIDED TO BRING IN ANOTHER SYSTEM'S TOWER AND MAY CALL BACK IF FURTHER ASSISTANCE IS NEEDED. THE PROCEDURE WAS ABORTED TO ANOTHER DA VINCI SYSTEM PRIOR TO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN A POWER SURGE OCCURS IN THE HOSPITAL, IT KNOCKS DOWN THE COMMON COMPUTER CONTROLLER (CCC). THE CCC REVERTS TO ITS INITIAL MANUFACTURING STATE AND WILL REMAIN IN THE HUMAN-USE SOFTWARE STATE. IT THEN DISPLAYS ERROR 311: GOLDEN IMAGE RUNNING. THE FIELD SERVICE ENGINEER MUST GO TO THE SITE AND RE-PROGRAM THE CCC BACK TO THE HUMAN-USE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58907 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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