BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24695765 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18657
    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
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE PROCEDURE EXTENDED LONGER THAN USUAL DUE TO CHALLENGING ANATOMY. TOWARDS THE END OF THE CASE, WHILE THE TEAM WAITED FOR THE COLLAPSED LUNG TO RETURN, THE DA VINCI SYSTEM WAS UNDOCKED, AND THE SURGEON USED THE ENDOSCOPE HANDHELD. SUDDENLY, THE SYSTEM¿S POWER BREAKER AUDIBLY TRIGGERED, AND UPON RESTARTING, IT FAULTED WITH ERROR 41107, RESULTING IN NO VIDEO FEEDS. THE STAFF SWIFTLY SWITCHED TO A STRYKER 1788 LAPAROSCOPIC SYSTEM, WHICH WAS ALREADY IN USE, AND DID NOT ATTEMPT TO TAP "RETRY" TO RECOVER FROM THE FAULT. APPROXIMATELY ONE MINUTE LATER, THE SYSTEM FAULTED AGAIN WITH ERROR 31089. THE SYSTEM WAS NOT USED FURTHER, AND THE CIRCULATOR NURSE REPORTED THE INCIDENT TO DVSTAT. THE PROCEDURE WAS CONVERTED LAPAROSCOPICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A LOBECTOMY CASE, THE SURGICAL TEAM ENCOUNTERED CHALLENGES WHILE TRYING TO NAVIGATE THROUGH THE FISSURE PLANE DUE TO THE PATIENT'S COMPLEX ANATOMY. THIS PARTICULAR CASE WAS UNIQUE AS THEY WERE UTILIZING A MOLECULE CALLED CYTALUX FOR IMAGING, WHICH REQUIRED A LAPAROSCOPIC CAMERA TO VISUALIZE THE IMAGES. AFTER COMPLETING THE ROBOTIC PORTION OF THE SURGERY, THE SURGEONS WERE ASSESSING WHETHER THE LUNG WOULD INFLATE AND ATTEMPTED TO USE A HANDHELD ENDOSCOPE CAMERA. HOWEVER, A POWER SURGE AT THE HOSPITAL CAUSED A SYSTEM FAULT WITH ERROR CODE 41107, RESULTING IN THE LOSS OF VIDEO FEEDS. TO ADDRESS THIS, THE TEAM SWIFTLY TRANSITIONED TO A STRYKER 1788 LAPAROSCOPIC SYSTEM, WHICH WAS ALREADY SET UP AND AVAILABLE FOR USE. THE ISSUE WAS NOT RELATED TO THE ROBOTIC SYSTEM ITSELF BUT WAS ATTRIBUTED TO THE HOSPITAL'S POWER SURGE. CONSEQUENTLY, THE PROCEDURE EXTENDED ONE AND A HALF HOURS LONGER THAN A TYPICAL LOBECTOMY. 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. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOSPITAL OR STAFF CONFIRMED THAT THE POWER SURGE OCCURRED DUE TO STORM AND SOME HOSPITAL POWER ISSUES. WE INSTALLED GENERATORS ON EACH OPERATION ROOMS TO RESOLVE THE POWER SURGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403195 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

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