DAVINCI XI
Report
- Report Number
- 2955842-2022-15303
- Event Type
- Malfunction
- Date Received
- November 17, 2022
- Date of Event
- October 17, 2022
- Report Date
- October 17, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED A U-02 ERROR ON THE ERBE. THE FSE REPLACED THE ERBE AND PERFORMED SYSTEM VERIFICATION. THE SYSTEM WAS TESTED AS READY FOR USE. ISI DID RECEIVE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND CONFIRMED THE U-02 ERROR. THE COMPLAINT REGARDING U-02 ERROR WAS CONFIRMED BASED ON FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR SUPPORT. INVESTIGATION REVEALED ERRORS U-2 ON THE IESU OCCURRED DURING THE SURGICAL PROCEDURE THAT WERE RELATED TO THE REPORTED COMPLAINT. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: AN INCISIONAL HERNIA IPOM PROCEDURE WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE ELECTROSURGICAL GENERATOR UNIT (ESU) WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP 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.
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED INCISIONAL HERNIA IPOM SURGICAL PROCEDURE, U-02 ERRORS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WERE DISPLAYED. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN TO REPORT THE ERROR ON THE IESU EVERY TIME THEY TRIED TO POWER IT ON OR USE THE GENERATOR. THE ISI TECHNICAL SERVICE ENGINEER (TSE) REVIEWED LOGS AND FOUND SEVERAL U-02 ERRORS ON THE IESU. THE ISI TSE WALKED THE CUSTOMER THROUGH A HARD POWER CYCLE OF THE IESU AND THE VISION SIDE CART (VSC), BUT THE ERROR RETURNED. THE ISI TSE INFORMED THE CALLER THAT THE ERBE WILL NEED TO BE REPLACED AND A THIRD-PARTY FORCE TRIAD WOULD BE NEEDED TO BYPASS THE UNIT. THE CALLER CONFIRMED THE FORCE TRIAD WAS BROUGHT IN FROM ANOTHER ROOM. THE ISI TSE REMINDED THE CUSTOMER THAT A SPECIFIC ACTIVATION CABLE WAS NEEDED FOR THE THIRD-PARTY GENERATOR AND CONFIRMED THEY REQUIRED NO FURTHER ASSISTANCE SETTING UP THE DEVICE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE PLACED WHEN THE ISSUE WAS IDENTIFIED. THE SYSTEM WAS POWERED ON WITH NO ERRORS. THE IESU WAS NOT POWERED OFF IN BETWEEN THE CASES AND IT STARTED FAULTING WHILE PREPARING IT FOR THE CASE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. THERE IS NO PATIENT INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417295 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 381121-17 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |