BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23352642 · Received October 21, 2025

    Report

    Report Number
    2955842-2025-42454
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT, NO ADDITIONAL PORTS PLACED, AND NO CONVERSION TO LAPAROSCOPIC OR OPEN SURGERY. THE SURGEON COMPLETED THE CASE AND HAD NO ISSUES WITH THEIR CONSOLE, CONSOLE 1. THE RESIDENT'S CONSOLE, CONSOLE 2, WAS NOT CONNECTING. THIS WAS DISCOVERED AFTER DOCKING AND PORTS WERE PLACED. THEY CALLED TECHNICAL SUPPORT AND TRIED BASIC TROUBLESHOOTING SUCH AS TRYING A NEW FIBER CABLE. CONSOLE 1 WORKED AS USUAL FOR THE ENTIRE CASE WITH NO ISSUE OTHER THAN THE RESIDENT NOT BEING ABLE TO SEE FROM CONSOLE 2.

    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 RESOLVED THE ISSUE BY REPLACING THE BLUE FIBER PIGTAIL CABLE AND RECEPTACLE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO AN INOPERATIVE FIBER PORT.

    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 RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, ONE OF THE CONSOLES WAS NOT SHOWING THE ENDOSCOPE VIEW. THE CLINICAL TERRITORY ASSOCIATE (CTA) STATED THAT BOTH CONSOLE LEDS WERE BLUE. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND CONFIRMED ONLY ONE OF THE CONSOLES WAS CONNECTED TO THE SYSTEM. THE TSE RECOMMENDED TO CHECK THE BLUE FIBER CABLE. THE CTA STATED THAT THERE WAS NO BLUE LED ON BOTH ENDS OF THE CABLE. THE CTA ATTEMPTED TO CLEAN THE CABLE ON BOTH ENDS AND EVEN SWAPPED OUT THE CABLE WITH A SPARE, BUT THE ISSUE DID NOT RESOLVE. THE TSE ADVISED THE CUSTOMER TO POWER DOWN THE SYSTEM AFTER THE CASE, CLEAN BOTH PORTS WITH COMPRESSED AIR, PERFORM A HARD POWER CYCLE ON THE TOWER AND SUSPECT CONSOLE, AND RESEAT THE FIBER CABLE. THE TSE INSTRUCTED TO POWER THE SYSTEM BACK ON TO SEE IF BOTH CONSOLES POWER ON AFTER COMPLETING THE TROUBLESHOOTING STEPS. THE SITE WAS PROCEEDING WITH THE CASE. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840566 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES