DAVINCI 5
Report
- Report Number
- 2955842-2026-14916
- Event Type
- Malfunction
- Date Received
- March 3, 2026
- Date of Event
- February 11, 2026
- Report Date
- April 7, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119747
- PMA / PMN Number
- K232610
- Removal / Correction Number
- ISIFA2025-17-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
ON 04/06/2026, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: ROBOT HAD ERROR CODE THAT LOCKED UP ROBOT ARMS. INTUITIVE HELP LINE ADVISED TO SHUT SYSTEM DOWN AND THEN RESTART AND IF NO ERROR THEN PROCEED. ROBOT RESTARTED AND NO ERROR CODE. PATIENT PREPPED, SEDATED, INTUBATED. ROBOT THREW ERROR CODE AGAIN. PATIENT RECOVERED AND THEN RESCHEDULED. NO HARM TO PATIENT.
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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE CARDCAGE AND VIEWER TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.
THIS VIEWER UNIT WAS RETURNED FOR FAILURE ANALYSIS DUE TO A REPORTED 307 ERROR. THE ISSUE WAS REPLICATED ON SITE. SYSTEM LOGS CONFIRMED THE OCCURRENCE OF ERROR 307. TROUBLESHOOTING INDICATED THAT THE ERROR WAS RELATED TO THE VIEWER. THE VIEWER WAS REPLACED TO ADDRESS THE REPORTED ISSUE. A VISUAL INSPECTION REVEALED NO PROBLEMS RELATED TO THE REPORTED ISSUE. THE LIGHTHOUSE/APERTURE WAS CHECKED, CONFIRMING THE OCCURRENCE OF ERROR 307. THE VIEWER WAS INSTALLED ON AN INTERNAL EFT SYSTEM AND FUNCTIONED AS DESIGNED. THE REPORTED ISSUE COULD NOT BE REPLICATED DURING SYSTEM TESTING. THE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THIS CONSOLES CARDCAGE ASSEMBLY WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERROR 307 WAS CONFIRMED BUT NOT REPLICATED. IN LIGHTHOUSE, THIS ERROR 307 INDICATED THAT A NODE WAS NOT PRESENT AT STARTUP AND THAT IT DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. THIS SSC CARDCAGE ASSEMBLY WAS INSTALLED, SUCCESSFULLY PROGRAMMED, AND TESTED ON A DV5 IN-HOUSE GOLDEN SYSTEM WITH NO ISSUES OR ERRORS TRIGGERED AT STARTUP. MULTIPLE POWER CYCLES WERE RUN WITH NO FAILURES OR ERRORS TRIGGERED. THE UNIT IDLED FOR 1.5 HOURS IN NORMAL MODE WITH NO ISSUES OR ERRORS TRIGGERED. SYSTEM BOOT-UP WAS NORMAL AS EXPECTED. REVIEWING THE HISTORY AND ERROR LOGS, THIS ERROR POINTED TO OTHER NODES NOT RELATED TO THIS UNIT, SPECIFICALLY POINTING TO THE CONSOLE VIEWER, WHICH WAS ALSO REPLACED FOR THE SAME ERROR. AS A RESULT OF THIS TEST AND FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE POTENTIAL ROOT CAUSE COULD BE ATTRIBUTED TO THE CONSOLE VIEWER IN RELATION TO THE REPORTED EVENT.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT THE OR STAFF CONTACTED TECHNICAL SUPPORT BEFORE A PROCEDURE TO REPORT THAT THE SYSTEM DISPLAYED A 307 FAULT, WAS REBOOTED, AND THEN DISPLAYED ANOTHER 307 FAULT. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE EVENTS AND IDENTIFIED ERROR 307 RELATED TO THE SDCH. THE TSE ADVISED THE CALLER THAT THE FAULT WAS LIKELY TO PERSIST AND SUGGESTED INFORMING THE SURGEON TO DECIDE ON THE NEXT STEPS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590327 | DAVINCI 5 | SURGEON SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380730-45 | N/A | 00886874119747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | DA VINCI INSTRUMENTS AND ACCESSORIES. |