DAVINCI SI
Report
- Report Number
- 2955842-2025-17928
- Event Type
- Injury
- Date Received
- May 2, 2025
- Date of Event
- April 3, 2025
- Report Date
- April 3, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110782
- PMA / PMN Number
- K081137
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY REMOVING THE EXTERNAL DVI CABLE CONNECTED TO PMSC ON THE SURGEON CONSOLE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.
CORRECTED DATA CAN BE FOUND IN THE FOLLOWING FIELDS: B1, B2, H1, AND H6.
WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE FINDINGS OF FAILURE ANALYSIS AND FIELD EVALUATION, POSSIBLE CAUSES FROM FAILURE ANALYSIS AND FIELD EVALUATION WERE LINKED TO ELECTRICAL/FIBEROPTIC DEFECTS THAT MAY BE ASSOCIATED WITH THE HIGH RESOLUTION STEREO VIEWERS MONITOR 3 (RIGHT) AND GENERIC CART CONTROLLER, PERSONALITY MODULE SURGEON CONSOLE 12.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SURGEON BACK PLANE (SBP), PERSONALITY MODULE SURGEON CONSOLE (PMSC), MASTER TOOL MANIPULATOR (MTM), HIGH RESOLUTION STEREO VIEWER (HRSC), AND GENERIC CART CONTROLLER (GCC) TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO REPRODUCE NOR CONFIRM THE REPORTED COMPLAINT FOR THE SBP. DURING VISUAL INSPECTION, FA FOUND NO ISSUES RELATED TO THE REPORT ISSUE. THE SBP WAS INSTALLED AND TESTED INTO A GOLDEN PRINTED CIRCUIT ASSEMBLY SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE SYSTEM STARTED UP WITHOUT ANY ERROR. RAN 10X POWER CYCLE WITH THIS PART, ALL PASSED. EXERCISING ALL ARMS WITH NO ISSUE. THE SBP REMAINED ON THE TEST SYSTEM FOR HOURS. AS A RESULT OF THESE FINDINGS, FA CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE. FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE THE REPORTED COMPLAINT DURING IN-HOUSE TESTING FOR THE PMSC. DURING VISUAL INSPECTION, FA FOUND THE UNIT HAD CORROSION. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE PMSC. IT FAILED ERROR 45308. REPLICATING THE REPORTED EVENT. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT PMSC WAS FOUND TO BE THE ROOT CAUSE THE REPORTED EVENT. FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE DURING IN-HOUSE TESTING FOR THE HOMING ERROR ON THE MTM. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE SINE CYCLE WAS FOUND TO BE FAILING ON THE AXIS 5-7. ONCE TESTING WAS COMPLETED, THE AXIS 5-7 MOTORS WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT THE AXIS 5-7 MOTORS AND WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. FA WAS NOT ABLE TO CONFIRM NOR REPRODUCE THE REPORTED COMPLAINT FOR THE HRSV (#1). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITOR WAS INSTALLED ON OUR PCA TEST SYSTEM. IT STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. AS A RESULT OF THESE FINDINGS, FA WAS UNABLE TO DETERMINE TOOT CAUSE. FA WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING FOR THE HRSV (#2). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITOR WAS INSTALLED AND TESTED ON THE PCA TEST SYSTEM. POWERED ON SHOWING A BLANK SCREEN. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT AN ELECTRICAL COMPONENT ISSUE IN THE MONITOR WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED FAILURE. FA WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS NOR REPRODUCE THE ISSUE DURING IN-HOUSE TESTING FOR THE GCC. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE GCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN THE GOLDEN SYSTEM WAS SET TO RUN VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, NO ERROR COULD BE IDENTIFIED. VIDEO TEST PASSED. AS A RESULT OF THESE FINDINGS, FA CONCLUDE THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE.
IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 48100 WAS NOTED DURING SURGERY. THE CUSTOMER HAD RECOVERED THE ERROR. THE TSE INFORMED THE CUSTOMER THAT THE ERROR WAS CAUSED BY THE FAULTY DIGITAL VIDEO INTERFACE (DVI) CABLE AT PMSC. THE TSE INSTRUCTED THE CUSTOMER TO REMOVE THE EXTERNAL DVI CABLE CONNECTED TO PMSC ON THE SURGEON SIDE CART. THE CUSTOMER FOLLOWED THE INSTRUCTIONS AND REMOVED THE CABLE. THE TSE INSTRUCTED THE CUSTOMER TO RESTART THE SYSTEM CAN THE CUSTOMER WOULD CALL BACK TO CONFIRM. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY A WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH AS THE VISION WAS NOT AVAILABLE ON RIGHT EYE DUE TO WHICH SURGEON WAS UNABLE TO SEE 3D IMAGE AND WOULD HAVE CAUSED POTENTIAL RISK. THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION BY ADDING ADDITIONAL PORT IN EPIGASTRIUM FOR LAP WORKING PORT. THE PATIENT DID TOLERATE THE CHANGE AND THERE WAS NO INJURY TO THE PATIENT. ACTIONS TAKEN TO RESOLVE THE ISSUE WERE TROUBLESHOOTING BEING PERFORMED AS INSTRUCTED BY DVSTAT( RESTART AND HARD CYCLE) BUT SITUATION REMAINED THE SAME. THE PROCEDURE WAS COMPLETED LAPROSCOPICALLY.
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 |
|---|---|---|---|---|---|---|---|
| 1024053 | DAVINCI SI | SURGEON SIDE CONSOLE, RECERTIFIED | NAY | INTUITIVE SURGICAL, INC | 380689-02 | N/A | 00886874110782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES. |