DAVINCI SI
Report
- Report Number
- 2955842-2022-11065
- Event Type
- Malfunction
- Date Received
- April 15, 2022
- Date of Event
- March 16, 2022
- Report Date
- March 16, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110874
- PMA / PMN Number
- K081137
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO PROACTIVELY INVESTIGATE THE REPORTED COMPLAINT. FSE PERFORMED A PREVENTIVE REPLACEMENT OF THE SUSPECT IESU. FOLLOWING THIS, THE SYSTEM WAS FURTHER TESTED, OPERATED WITHOUT EXHIBITING ANY ERROR AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE IESU WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A THIRD-PARTY ESU. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT CONFIRM AND REPRODUCE THE REPORTED FAILURE. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THERE WAS NO PROBLEM DETECTED.
IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER (NURSE) CALLED IN TO REPORT THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE INITIALLY WORKED FOR 5 MINUTES AND THEN APPEARED TO HAVE SHUT DOWN. DUE TO THIS, THE CUSTOMER WAS UNABLE TO USE THE VESSEL SEALER INSTRUMENT. THE CUSTOMER MENTIONED THAT THE IESU SCREEN AND THE LED ARE ALL OFF. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO DOUBLE CHECK IESU POWER BUTTON POSITION, BREAKER POSITION, RESEAT THE POWER CORD AND TO FOLLOW POWER SOCKET PATH (ENSURING PROPER CONNECTION). THE CUSTOMER STATED THAT THEY HAVE DONE THAT WITH NO RESOLVE. THE CUSTOMER ELECTED TO USE AN EXTERNAL ENERGY DEVICE TO CONTINUE WITH THE SURGICAL TASK AND CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT WAS FURTHER REPORTED THAT AFTER COMPLETING THE PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER VIA A PHONECALL AND CONFIRMED THAT THE IESU WAS CHECKED AND EXHIBITED NO ISSUE. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION ON 29-MARCH-2022. IT WAS CONFIRMED THAT THE VESSEL SEALER INSTRUMENT WAS WORKING INITIALLY AND THEN STOPPED DUE TO AN IESU ISSUE. THE DA VINCI SYSTEM WAS DOCKED AND ALL PORTS WERE IN SITU. ALSO, PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED, BUT NOT PROVIDED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1907637 | DAVINCI SI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 380990-16 | N/A | 00886874110874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | DA VINCI INSTRUMENTS AND ACCESSORIES |