DAVINCI 5
Report
- Report Number
- 2955842-2025-34713
- Event Type
- Malfunction
- Date Received
- August 19, 2025
- Date of Event
- July 24, 2025
- Report Date
- November 26, 2025
- 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
- OH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO REPRODUCE THE ERROR. THE FSE PERFORMED THE SUGGESTED TEST; HOWEVER, THE SYSTEM WOULD ERROR OUT IN APERTURE DUE TO MISSING "NODES". AS A RESULT, FSE COULD NOT RUN COLUMN CALIBRATION. THE CABLE CONNECTION J33, J34, J35, AND J38 ON ACPB WERE CHECKED WITH NO IMPROVEMENT. THE FSE RETURNED ON DIFFERENT DAY FOR ADDITIONAL TROUBLESHOOTING. THE SYSTEM WAS CONNECTED, AND TECH SUPPORT WAS CONTACTED. PROGRAMMING THE PATIENT SIDE CART (PSC) STAND ALONE TO 1.2 SOFTWARE USING APERTURE O2 DOWNLOAD APP AUX WAS ATTEMPTED, BUT ERRORS WERE REPORTED ON POWER NODE CONFIGURATION FOR EACH ARM NET. MULTIPLE PROGRAMMING ATTEMPTS WERE MADE, BUT THE SAME ERROR PERSISTED. IT WAS ALSO NOTED THAT MISSING NODES WERE REPORTED DURING EACH PROGRAMMING ATTEMPT. THE PATIENT CART HANDLE SENSOR (PCHS), AND AC 4 B THROUGH AC 4 F WERE MISSING NODES AND COULD NOT BE SEEN ON THE SYSTEM CONFIGURATION TAB. AXES CONTROLLER PLATFORM DUAL (ACPD) WAS REPORTING ERRORS THAT APPEAR TO BE A PROGRAMMING / SECURITY ISSUE. ON A SUBSEQUENT VISIT, THE FSE RETURNED WITH REPLACEMENT PART, INCLUDING DISTAL SUJ, PCHS, ACP, ACPD AND ACPB. ALL PARTS WERE REPLACED WITH NO CHANGE IN SYSTEM BEHAVIOR. WHEN POWERING UP THE SYSTEM, IT WAS NOTED THAT USM 4 FANS WERE POWERED UP. WHILE ON A TROUBLESHOOTING CALL WITH PRODUCT SUPPORT, THE FSE SWAPPED FRM CONNECTORS FOR UNIVERSAL SURGICAL MANIPULATOR (USM) 3 AND 4 WITH NO CHANGE IN SYSTEM BEHAVIOR. THE FSE SWAPPED ARM NET POWER CONNECTORS AT THE CARD CAGE FOR 3 AND 4 BUT THE BEHAVIOR DID NOT CHANGE. ANY PROGRAMMING ATTEMPTS OR FIELD REPLACEABLE UNITS (FRU) COMPONENT SWAPS MADE HAD ZERO CHANGE ON THE SYSTEM AND THERE WERE NO FURTHER SOLID RECOMMENDATIONS FOR ATTEMPTED TROUBLESHOOTING. THE FSE INSTALLED A REPLACEMENT PSC CART TO RESOLVE THE ISSUE. AN RMA WAS INITIATED FOR THE RETURN OF PSC, CFG PCE, PCA ACPB, CFG PCHS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. ISI DID RECEIVE THE PCA ACPB, CFG PCHS PARTS HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.
THE CFG PATIENT CART COMPUTE ENGINE (PCE) WAS EVALUATED BY FAILURE ANALYSIS AND THE ISSUE WAS CONFIRMED VIA LIGHTHOUSE. THE CFG PCE WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE CFG PCE WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WITH NO ISSUES. THE PSC WAS MOVED THROUGHOUT ITS RANGE OF MOTION WITH NO ISSUES. THE UNIT WAS LEFT TO IDLE FOR 16 HOURS, AND POWER CYCLED FIVE TIMES WITH NO ISSUES. AS A RESULT OF THESE FINDINGS, NO ROOT CAUSE COULD BE DETERMINED. FIELD H8 CORRECTED TO INITIAL USE.
THE AXES CONTROLLER PLATFORM BACKPLANE (ACPB) PRINTED CIRCUIT ASSEMBLY (PCA), PATIENT CART HANDLE SENSOR (PCHS) CFG WAS RETURNED AND EVALUATED BY FAILURE ANALYSIS TEAM. THE PCHS CFG WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERRORS 23008 AND 23062 WERE CONFIRMED BUT NOT REPLICATED. IN ARTEMIS, THESE ERRORS 23008 AND 23062 WERE FOUND INDICATING AND CONFIRMING THAT THESE FAULTS DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS PCHS CFG WAS INSTALLED, PROGRAMMED, AND TESTED ON THE PCA IS4000 SYSTEM, WITH NO ISSUE ON STARTUP AND NO ERRORS OR FAILURES WERE TRIGGERED. THIS ASSY WENT THROUGH 12 POWER CYCLES WITH NO ISSUE, IDLE IN NORMAL MODE FOR 1 HOUR. PERFORM ADDITIONAL TEST PER (B)(4) REV I, IN PROCESS CORRECTION VERIFICATION AND ALL TEST PASSED. ADDITIONALLY, IT WAS NOTED THAT REPLACING THESE PCHS CFG UNIT DID NOT RESOLVE THE RESOLVE THE ROBOT BOOM ISSUE. AS A RESULT OF THIS TEST AND FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE WITH THIS PCHS CFG BOARD COULD BE ATTRIBUTED TO THE REPORTED EVENT. THIS ACPB PCA UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERRORS 23008 AND 23062 WERE CONFIRMED BUT NOT REPLICATED. IN ARTEMIS, THESE ERRORS 23008 AND 23062 WERE FOUND INDICATING AND CONFIRMING THAT THESE FAULTS DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS ACPB PCA ASSEMBLY WAS INSTALLED, PROGRAMMED, AND TESTED ON THE PCA IS4000 SYSTEM, RUN 10X POWER CYCLES WITH NO ISSUE ON STARTUP AND NO ERRORS OR FAILURES WERE TRIGGERED. THIS ACPB REMAINS ON THE SYSTEM IDLING IN NORMAL MODE FOR TWO DAYS WITH NO ISSUE. ADDITIONALLY, TESTS WERE PERFORMED PER IPC (B)(4) REV I AND ALL TESTS PASSED. ADDITIONALLY, IT WAS NOTED THAT REPLACING THIS ACPB PCA UNIT DID NOT RESOLVE THE BOOM ISSUE AFTER REPLACEMENT. AS A RESULT OF THIS TEST, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THE REPORTED EVENT.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE OPERATION ROOM (OR) STAFF CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THEY ARE HAVING BOOM ISSUES. TH CUSTOMER COMPLETED DRAPING THE ARMS AND WHEN THEY WENT TO DEPLOY FOR DOCKING, THE SYSTEM ENCOUNTERED A FAULT. THE CALLER STATED THEY TRIED MULTIPLE RETRIES AND ONE RESTART BEFORE CALLING IN. THE FAULT ON THE SCREEN IS SHOWING 23008. THE TSE HAD THEM RESTART ONCE MORE AND WAS ABOUT TO DO A HARD POWER CYCLE, BUT PATIENT WAS ALREADY CONNECTED TO INSUFFLATION AND NO HARD POWER WAS DONE. THE SECOND RESTART DID NOT CLEAR THE FAULT. THE TSE ASKED IF THEY HAVE ANOTHER DV5 ROBOT THEY CAN SWAP, THE CALLER WAS ABLE TO GET THE ROBOT FROM SQ0889. THE ROBOT WAS SWAPPED WAS SUCCESSFUL. THE STAFF WAS ABLE TO DEPLOY FOR DOCKING AND INSERT INSTRUMENTS. THE CUSTOMER WAS TRYING TO REMOVE THE BAD ROBOT OUT OF THE ROOM, BUT THE BOOM WAS TOO HIGH. THE TSE HAD CALLER HARD POWER CYCLE THE BAD ROBOT ONCE MORE, BUT THE FAULT STILLED APPEARED ON STANDALONE. THE CALLER HAD TO GO, AND NO MORE TROUBLESHOOTING WAS DONE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY/HARM TO THE PATIENT.
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 |
|---|---|---|---|---|---|---|---|
| 252436 | DAVINCI 5 | PATIENT SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380747-42 | N/A | 00886874119716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |