DAVINCI 5
Report
- Report Number
- 2955842-2025-41090
- Event Type
- Malfunction
- Date Received
- October 8, 2025
- Date of Event
- September 16, 2025
- Report Date
- November 21, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K232610
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE CONSOLE COMMON COMPUTE CONTROLLER (CCC) WAS VISUALLY INSPECTED WITH NO ISSUES FOUND. THE FIELD ERROR LOGS WERE REVIEWED WITH NO ERRORS PERTAINING TO THE CONSOLE CCC. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE POWERED THE SYSTEM ON AND RECEIVED AN ERROR 48305. THE ROBOT WOULD POWER ON, BUT THE UNIVERSAL SURGICAL MANIPULATORS (USM) WOULD NOT INITIALIZE AND LIGHTS WOULD NOT ILLUMINATE. THE FSE REVIEWED THE ERROR LOGS AND FOUND MULTIPLE 48305 AND 40097 ERRORS POINTING TO THE ROBOT COMMON COMPUTE CONTROLLER (CCC) AND ALSO 48293 ERRORS ON ALL FIVE ARMNETS. THE FSE POWERED THE SYSTEM DOWN AND POWERED THE ROBOT ON IN STANDALONE MODE. THE USMS WOULD STILL NOT INITIALIZE AND LIGHTS WOULD NOT ILLUMINATE. BASED ON ERROR LOGS AND USMS NOT INITIALIZING, THE ISSUE IS LIKELY WITH THE ROBOT CCC OR CARD CAGE, NOT A SINGULAR USM. THE FSE REPLACED THE ROBOT CCC, THE CONSOLE CCC, AND THE USM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE REPORTED ERRORS 319 WERE CONFIRMED TO HAVE OCCURRED DURING THE CASE VIA THE SYSTEM LOGS AND WERE REPLICATED DURING FA. UPON VISUAL INSPECTION, THE ROLLING LOOP WAS MANGLED AND STICKING OUT. THE COMPLAINT DETAIL FROM THE FIELD SHOWED ERROR 319 WITH A P1 VALUE = AC_3F_ID. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 319 ERROR WAS TRIGGERED DURING SYSTEM STARTUP. THE ERROR LOG P1 VALUE = AC_1F POINTS TO THE AXES CONTROLLER, CARRIAGE POWER (ACCP). THE COMPLAINT WAS CONFIRMED BASED ON FA, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. BASED ON THESE FINDINGS, IT WAS CONCLUDED THAT THE ROLLING LOOP FIBER CABLE WAS THE ROOT CAUSE OF THE REPORTED EVENT.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ROBOT COMMON COMPUTE CONTROLLER (CCC) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED ERROR 48305 DOES NOT PERTAIN TO THE ROBOT CCC. THEREFORE, THE FAILURE WAS NOT CONFIRMED NOR REPLICATED. IN THE SYSTEM LOGS, ERROR 48305 WAS FOUND CONFIRMING THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ROBOT CCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE FIBER OPTIC LIGHT LEVELS ON THE CCC WERE INSPECTED WITH LOCALHOST:8050 AND ALL VALUES WERE WITHIN EXPECTATION. TEN POWER CYCLES WERE PERFORMED AND THE CCC WAS LEFT IN THE GOLDEN SYSTEM TO IDLE FOR TWO HOURS WITH NO ISSUES FOUND.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE TRANSVESICAL PROSTATECTOMY SURGICAL PROCEDURE, LOGS SHOWED ERROR 319 ON ARMNET 3 AND ADDITIONAL ERRORS ON CONSOLE 1. THE CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT UNPLUGGING CONSOLE 1 DID NOT RESOLVE THE 319 ERRORS. THE SITE DECIDED TO SWITCH TO A DIFFERENT SYSTEM WHILE MID-CASE. LOGS DID NOT FULLY LOAD FOR REVIEW. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED HALFWAY THROUGH THE PROCEDURE. THE CUSTOMER BROUGHT IN ANOTHER DA VINCI 5 FROM A NEARBY ROOM TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DA VINCI COORDINATOR CONFIRMED THAT THEY INITIALLY ENCOUNTERED THE REPORTED ISSUE PRIOR TO PATIENT INVOLVEMENT WHILE STARTING UP THE SYSTEM. HOWEVER, SYSTEM FAULTS RETURNED HALFWAY THROUGH THE PROCEDURE.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2512499 | DAVINCI 5 | PATIENT SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380747-40 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | DA VINCI INSTRUMENTS AND ACCESSORIES |