DAVINCI 5
Report
- Report Number
- 2955842-2025-38993
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 3, 2025
- Report Date
- December 4, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K232610
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 NOT CONFIRMED. FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED PN: 373750-20 INSUFFLATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE INSUFFLATOR FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.
THE ROOT CAUSE IS ATTRIBUTED TO AN AIR LEAKAGE CAUSING A LOOS OF INSUFFLATION WHICH WAS DETECTED BY THE SYSTEM TRIGGERING "TANK LEVEL EXTREMELY LOW". THIS ISSUE CAN BE RESOLVED BY REPLACING THE UNIT.
THIS UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED COMPLAINT WAS CONFIRMED AND REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO THE KNOWN GOOD IN-HOUSE SYSTEM AND POWERED ON WITH NO ISSUES. THE UNIT WAS LEFT IDLE, AND THE ERROR MESSAGE "TANK LEVEL EXTREMELY LOW" APPEARED. THE UNIT IS LEAKING AIR. FROM THESE FINDINGS, FAILURE ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE OF THE ISSUE. THE UNIT WILL BE RETURNED TO THE OEM FOR POTENTIAL REPAIR. H8 "USAGE OF DEVICE" FIELD WAS CORRECTED TO INITIAL USE OF DEVICE.
IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SALPINGO OOPHORECTOMY SURGICAL PROCEDURE, THE INSUFFLATOR WAS NOT WORKING, DISPLAYING A "HOUSE GAS LOW" MESSAGE. THE OPERATING ROOM STAFF CALLED TECHNICAL SUPPORT, AND THE TECHNICAL SUPPORT ENGINEER FOUND NO RELATED ERRORS IN THE AVAILABLE LOGS. BEFORE CALLING, THE CUSTOMER HAD CHECKED THE HOUSE GAS SOURCE, WHICH WAS SET TO 56 PSI, BUT THE MESSAGE PERSISTED, AND THE INSUFFLATOR WAS GRAYED OUT. THE ENGINEER GUIDED THE CALLER THROUGH A HARD POWER CYCLE OF THE TOWER, BUT THE SYSTEM POWERED BACK ON WITH THE LOW GAS PRESSURE MESSAGE STILL PRESENT. THE CUSTOMER CONFIRMED THE GAS PRESSURE SETTING WAS 56 PSI. TO PROCEED WITH THE PROCEDURE, THE CUSTOMER OPTED TO USE AN AIR SEAL UNIT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CASE WAS FINISHED AS PLANNED, THERE WAS A DELAY ABOUT 29 MINUTES. THE GAS WAS GRADUAL AT FIRST THEN WENT TO NOTHING WHEN TRIED TO REBOOT, SYSTEM WENT GREY AND INTUITIVE CALLED. AIRSEAL BROUGHT IN FOR THE REMAINDER OF THE CASE AND THEN OTHER CASES UNTIL ENGINEER ABLE TO COME.
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 |
|---|---|---|---|---|---|---|---|
| 542226 | DAVINCI 5 | VISION SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380746-45 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | DA VINCI INSTRUMENTS AND ACCESSORIES. |