DAVINCI 5
Report
- Report Number
- 2955842-2025-12375
- Event Type
- Malfunction
- Date Received
- April 1, 2025
- Date of Event
- March 12, 2025
- Report Date
- March 13, 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
- AR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED 2955842-2025-12372 IS A RELATED RECORD OF (B)(4). 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: 1200 - PCE (ARMNET 1) POWER MONITOR DETECTED AN ADC VALUE VER THE SET ERROR LIMIT THRESHOLD. A REVIEW OF SYSTEM LOG REPORT WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL # (B)(6), EVENT DATE - 3/12/2025, CONSOLE SURGEON AND PROCEDURE NAME/CATEGORY. DEVICE HISTORY RECORD (DHR) REVIEW-DHR REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE IN THIS CASE IS ATTRIBUTED TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND THIS ISSUE WAS RESOLVED BY REPLACING THE UNIVERSAL SURGICAL MANIPULATOR (USM).
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 PN: 380666-25 UNIVERSAL SURGICAL MANIPULATOR (USM) 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.
THE UNIT WAS RETURNED, AND FAILURE ANALYSIS WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED ISSUE. A VISUAL INSPECTION WAS PERFORMED, AND NO PROBLEM RELATED TO THE REPORTED ISSUE WAS FOUND. THE REPORTED ERROR 1200, ERROR_POWER_MON_OVER_LIMIT, WAS CHECKED AND VERIFIED IN THE LIGHTHOUSE (APERTURE). THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS INSTALLED ON AN INTERNAL EFT SYSTEM AND POWERED ON. THE SYSTEM POWERED ON WITHOUT ANY ERRORS OR FAILURES, SO INSTRUMENTS WERE INSTALLED, AND THE SYSTEM WAS DRIVEN. DURING THE DRIVE, THERE WERE NO ERRORS OR FAILURES, SO THE INSTRUMENTS WERE REMOVED, AND THE SYSTEM WAS POWER CYCLED AND DRIVEN SEVERAL MORE TIMES, STILL WITH NO ERRORS OR FAILURES. AFTER CONSULTING WITH ENGINEERS, IT WAS DETERMINED THAT THE REPORTED ERROR 1200 (POWER OVER LIMIT) IS MOST LIKELY NOT RELATED TO THIS USM, AS THE ERROR WAS REPORTED BY THE PCE PCA, WHICH IS A UCE1 NODE BUT OUTSIDE THIS USM.
THE PN: 658350-21 PATIENT CART COMPUTE ENGINE (PCE) CFG WAS ANALYZED AND FOUND FAILURE ANALYSIS INVESTIGATIONS THEY WERE UNABLE TO REPLICATE OR CONFIRM THE REPORTED ISSUE. PERFORMED A VISUAL INSPECTION AND FOUND NO PROBLEM RELATED TO THE REPORTED ISSUE. VERIFIED ERROR 32145 IN LIGHTHOUSE (APERTURE), THEN INSTALLED ON AN INTERNAL EFT SYSTEM. POWERED THE SYSTEM ON AND CHECKED FOR FAILURE BUT WAS UNABLE TO REPLICATE THE REPORTED ISSUE. NO ROOT CAUSE DETERMINED AT THIS TIME.
THE PROBABLE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED. THIS ISSUE WAS RESOLVED BY REPLACING THE USM.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, NON-RECOVERABLE FAULT ON SYSTEM. OPERATING ROOM STAFF REPORTED WHEN THE FAULT OCCURRED THE SURGEON CHOSE TO DISABLE THE ARM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A ROBOTIC POSSIBLE OPEN GASTROSTOMY TUBE PLACEMENT. THE CONSOLE SURGEON WAS (B)(6). THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THREE ARMS.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
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 |
|---|---|---|---|---|---|---|---|
| 1171009 | DAVINCI 5 | PATIENT SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380747-41 | N/A | 00886874119716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | DA VINCI INSTRUMENTS AND ACCESSORIES |