DAVINCI XI
Report
- Report Number
- 2955842-2025-02095
- Event Type
- Malfunction
- Date Received
- February 25, 2025
- Date of Event
- January 28, 2025
- Report Date
- January 28, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110898
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE REDUNDANT POWER TRAY ASSEMBLY INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA) AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REDUNDANT POWER TRAY ASSEMBLY WAS ANALYZED AND IN LOGS, THE ERROR 86 WAS FOUND INDICATING AN OUT-OF-RANGE VALUE WAS READ FROM THE IPD BOARD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS CORE REDUNDANT POWER TRAY ASSEMBLY WAS INSTALLED, PROGRAMMED, AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) IS4000 SYSTEM WHERE ERROR 86 WAS TRIGGERED DURING 1 HOUR OF NORMAL IDLING, REPLICATING THE REPORTED EVENT. REVIEWING THE REPAIR HISTORY LOGS, THIS IS THE SECOND TIME RETURN FOR ERROR 86. THE IPD CFG PN 651620-09 WAS REPLACED ON THE FIRST RETURN. TO TROUBLESHOOT THE ROOT CAUSE OF THIS REPORTED EVENT, THE REDUNDANT CORE POWER CONTROLLER PCA PN 354350-01 WAS ABA TESTED WITH SUCCESS, POWER CYCLES THE SYSTEM 12X WITH NO ERROR REPORTED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 86 INDICATING POWER DISTRIBUTION BOARD ADC FAULT - THE MSC SAW AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V. DESIGN HISTORY RECORD (DHR) REVIEW FOR THE SYSTEM INVOLVED WITH THE REPORTED EVENT WAS DEEMED NOT REQUIRED BY QUALITY ENGINEER SINCE THERE IS NO INDICATION OF A MANUFACTURING RELATED ISSUE. THE POTENTIAL ROOT CAUSE OF THE REPORTED EVENT COULD BE TO A FAILING REDUNDANT CORE POWER CONTROLLER BOARD.
IT WAS REPORTED THAT DURING DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT TWO NON-RECOVERABLE ERRORS. LOGS INDICATED ERROR 86 IS HAPPENING ON THE INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD). SITE PERFORMED A HARD POWER CYCLE ON THE TOWER AND WERE CONTINUING AS PLANNED. THE CSR CALLED REGARDING THE SYSTEM STATUS. CSR WANTED TO KNOW WHAT COMPONENT WAS AFFECTED. TSE EXPLAINED THAT THE POWER SUPPLY IN THE CORE WAS FAILING. THERE WAS A RECOMMENDATION TO REPLACE A COMPONENT IN THE CORE. CSR WANTED TO MAKE SURE IF THEY JUST EXCHANGED THE VISION TOWER WITH THEIR OTHER VISION TOWER, THEY COULD SAVE TIME. TSE EXPLAINED THAT IF THEY CHANGE OUT THE VISION TOWER, THEY SHOULD BE ABLE TO USE THE OTHER COMPONENTS WITH THEIR TOWER THAT THEY BRING INTO THE ROOM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1036735 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 381121-37 | N/A | 00886874110898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |