DAVINCI XI
Report
- Report Number
- 2955842-2024-22794
- Event Type
- Malfunction
- Date Received
- December 5, 2024
- Date of Event
- November 11, 2024
- Report Date
- November 11, 2024
- 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
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) WAS ANALYZED AND THE REPORTED FAILURE (C-83 ERRORS) WAS CONFIRMED AND REPRODUCED. THE LOGS SHOWED THE FAULT(S) OCCURRED IN THE FIELD. THE UNIT WAS PLACED ON A SURGEON SIDE CONSOLE AND WAS RUN IN NORMAL MODE.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (C-83 ERRORS) WAS CONFIRMED AND REPRODUCED ON IESU CONNECTED TO SURGEON SIDE CONSOLE. LOGS SHOWED (C-83 ERROR ON (B)(6) 2024) CONFIRMING THE FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION:(UNIT HAS DEEP SCRATCH SIDE COVER TO THE METAL.) (POWERED ON IESU AFTER THIRTY MINUTES ERRORS C-83/1-89/1-88 OCCURRED ON) IESU UNIT THAT WAS PLACED ON A SURGEON SIDE CONSOLE AND WAS RUN IN NORMAL MODE. (IIF HAS NOT RESPONDED AT THE PROPER TIME) FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE IESU.
INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT MULTIPLE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR ERRORS DURING USE. THE CUSTOMER WAS ABLE TO PROCEED WITH THE E-100 GENERATOR BUT WILL NEED MONOPOLAR ENERGY. THE TSE REVIEWED MULTIPLE 25913/M-02 ERRORS IN THE SYSTEM LOGS. THE TSE RECOMMENDED USING A THIRD-PARTY ENERGY DEVICE AS THE REPORTED M-02 ERRORS WILL CONTINUE TO REOCCUR. THE CUSTOMER HAS A VALLEY LAB IESU AVAILABLE BUT DOESN'T HAVE THE REQUIRED ENERGY CONNECTION CABLE FOR COMMUNICATION. THE CUSTOMER IS CONTINUING TO LOCATE THE REQUIRED CABLE AND WORKING WITH MANAGEMENT FOR A POSSIBLE ABORT TO ANOTHER DA-VINCI SYSTEM. THE CUSTOMER ENDED THE CALL AND WILL CALL BACK IF THEY DECIDE TO ABORT THE PROCEDURE. THE CUSTOMER LATER CALLED BACK INTO TECHNICAL SUPPORT AFTER LOCATING THE REQUIRED ENERGY CABLE TO CONNECT THEIR THIRD PARTY VALLEY LAB ENERGY DEVICE. THE THIRD PARTY ESU WAS CONNECTED AND THE CUSTOMER WAS CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THEY CONFIRMED THE PROCEDURE WAS COMPLETED ROBOTICALLY USING VALLEY LAB GENERATOR. THERE WAS A PROCEDURE DELAY OF LESS THAN 15 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1414537 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 381121-41 | N/A | 00886874110898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | DA VINCI INSTRUMENTS AND ACCESSORIES |