DAVINCI XI
Report
- Report Number
- 2955842-2023-17940
- Event Type
- Injury
- Date Received
- August 23, 2023
- Date of Event
- July 27, 2023
- Report Date
- July 27, 2023
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110720
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ON 12-OCT-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAS BEEN RECEIVED AND INVESTIGATION COMPLETED. FAILURE ANALYSIS INVESTIGATIONS DID NOT CONFIRM NOR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, PASSING RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THERE WERE NO ISSUES WITH UNCLAMPING DURING INSPECTION. NO GRIP MISALIGNMENT OR PHYSICAL DAMAGE DETECTED. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES.
ON 25-AUG-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE CARD CAGE UNIT HAS BEEN RECEIVED AND INVESTIGATIONS COMPLETED. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE CARD CAGE WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) (FAILURE ANALYSIS) TEST SYSTEM. THE SYSTEM WAS STARTED AND FAILED WITH ERROR 31221 ON THE UNIVERSAL POWER DISTRIBUTION (UPD) NODE OF THE PATIENT-SIDE POWER DISTRIBUTION BOARD (PPD) DOWNSTREAM OF THE CARD CAGE, WHICH MEANS THE HARDWARE HIGHSIDE SWITCH FAULT FIELD PROGRAMMABLE GATE ARRAY (FPGA) LOGIC HAS DETECTED A FATAL LOSS OF POWER AND ACTIVATED THE FAULT REACTION LOGIC (FRL). THIS FAULT SHOWS THE FRL HAS BEEN HIT. ARM 3 WAS NOT SHOWN ON THE GEMINI DOWNLOAD APP AND THERE WAS NO LIGHT. INSTALLED THE UCC (UNIVERSAL CONTROLLER CARD), 2 OF THE UMC (UNIVERSAL MOTION CONTROLLERS), AND UPD TEXT FIXTURE INTO THE CARD CAGE TO TROUBLESHOOT, ISSUE STILL OCCURRED. AFTER TROUBLESHOOTING THE CARD CAGE, THE UNIVERSAL BACKPLATE (UBP) SUB-COMPONENT WAS ISOLATED AS THE SOURCE OF THE ERROR.
ON 22-SEP-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PROGRASP FORCEPS INSTRUMENT WAS RECEIVED, AND INVESTIGATIONS WERE COMPLETED. FAILURE ANALYSIS INVESTIGATIONS DID NOT CONFIRM NOR REPLICATE THE CUSTOMER REPORTED COMPLAINT. NO PRODUCT ISSUE WAS IDENTIFIED. DURING VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, PASSING RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT WAS REMOVED FROM THE ROBOT EASILY WITHOUT USING THE RELEASE KIT ON MULTIPLE ATTEMPTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. IT PASSED RECOGNITION AND ENGAGEMENT TESTS AND THE GRIPS OPENED AND CLOSED PROPERLY. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. ON 25-SEP-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE INSTRUMENT RELEASE KIT (IRK) WAS RECEIVED, AND INVESTIGATIONS WERE COMPLETED. THE IRK WAS RETURNED WITH A PART FAILED COMPONENT AS AN INCIDENTAL RETURN. FAILURE ANALYSIS INVESTIGATIONS PERFORMED VISUAL INSPECTION AND NO DAMAGE WAS OBSERVED.
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE, REPRODUCED THE ISSUE, AND REPLACED THE PATIENT SIDE CART'S (PSC) CARD CAGE UNIT TO CORRECT THE REPORTED PROBLEM. THE PSC CARD CAGE INVOLVED WITH THIS EVENT HAS BEEN RECEIVED AND IS UNDERGOING FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE ISSUE WAS REPRODUCED BY THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED COMPLAINT. A REVIEW OF THE INSTRUMENT LOGS WAS PERFORMED AND FOUND NO ERRORS RELATED TO THE PROGRASP FORCEPS OR MARYLAND FORCEPS INSTRUMENTS. A REVIEW OF THE SYSTEM LOG WAS PERFORMED, AND SHOWED THE FOLLOWING POSSIBLE RELATED SYSTEM ERROR: * ERROR CODE 31221: THE HARDWARE HIGHSIDE SWITCH FAULT FPGA LOGIC HAS DETECTED A LOSS OF POWER. A REVIEW OF THE ADVANCED SYSTEM LOGS CAN CONFIRM THAT THIS SITE EXPERIENCED A NONRECOVERABLE ERROR 31221 ON THE UPD [UNIVERSAL POWER DISTRIBUTOR] PCA [PRINTED CIRCUIT ASSEMBLY]. THE UPD PCA MANAGED PSC [PATIENT SIDE CART] POWER CONTROL. THE 31221 ERROR INDICATES THAT A HIGHSIDE SWITCH EXPERIENCED A LOSS OF POWER. THIS IS LIKELY DUE TO A COMPONENT FAILURE WITHIN THE PSC CARD CAGE. THE FSE [FIELD SERVICE ENGINEER] REPLACED THE CARD CAGE ON 28-JUL-2023 AND NO FURTHER 31221 ERRORS HAVE OCCURRED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, THE SYSTEM ENCOUNTERED A NON-RECOVERABLE ERROR 31221. THE ISSUE OCCURRED PRIOR TO URETHRAL TRANSECTION WITH THE PROGRASP FORCEPS AND MARYLAND FORCEPS INSTRUMENTS GRASPING UNSPECIFIED TISSUE. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LIVE LOGS AND CONFIRMED ERROR 31221 INDICATING A POWER PROBLEM FROM THE UNIVERSAL POWER DISTRIBUTION (UPD) BOARD. A POWER CYCLE (RESTART) AND HARD CYCLE OF THE SYSTEM WERE ATTEMPTED BUT THE ERROR DID NOT RESOLVE. WHILE THE SYSTEM WAS DOWN, THE SURGEON SWITCHED TO A THIRD-PARTY LAPAROSCOPIC ENDOSCOPE TO RELEASE THE PROGRASP FORCEPS AND MARYLAND FORCEPS INSTRUMENTS USING AN INSTRUMENT RELEASE KIT (IRK). THE UNSPECIFIED TISSUE THAT WAS GRASPED WAS SAFELY RECOVERED. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO OPEN SO THE INSTRUMENTS WERE REMOVED WITH THEIR RESPECTIVE CANNULAS AND A MANUAL UNDOCKING WAS THEN PERFORMED. THERE WAS NO TISSUE DAMAGE AND NO UNEXPECTED TISSUE REMOVAL. NO BLEEDING WAS OBSERVED, AND NO BLOOD TRANSFUSION WAS ADMINISTERED. THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND INITIALLY POWERED ON WITHOUT ERRORS. THE COMPLICATION WAS NOT EXPECTED AS PART OF THE PROCEDURE. DVSTAT WAS CONTACTED PRIOR TO CONVERTING THE PROCEDURE AND FULL TROUBLESHOOTING WAS COMPLETED. THE PROGRASP FORCEPS AND MARYLAND FORCEPS INSTRUMENTS JAWS WERE NOT STUCK ON TISSUE BUT WERE GRASPING WHEN THE ISSUE OCCURRED. THE SURGEON BELIEVES THAT SINCE THE DA VINCI SYSTEM IS A MACHINE, IT IS INEVITABLE THAT THIS ISSUE MAY OCCUR. IT WAS DETERMINED THAT THE CONTROL UNIT (CART GAUGE UNIT) OF THE PATIENT SIDE CART (PSC) WAS MALFUNCTIONING, AND THE SYSTEM WAS RESTORED BY REPLACING THE UNIT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525166 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-54 | N/A | 00886874110720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | DA VINCI INSTRUMENTS AND ACCESSORIES. |