daVinci 5 380746Recalls & reported problems

Summary

The FDA's MAUDE database contains 457 adverse event reports that list this exact device (DI 00886874119662), received between May 2, 2024 and Sep 28, 2026 — classified as 2 deaths, 40 injuries, 415 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (248 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 24, 2026Open, Classified

   Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

   Z-2310-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 457 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926058 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926027 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926024 ↗
• MalfunctionSep 28, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925269 ↗
• MalfunctionSep 28, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci assisted surgical procedure, the customer contacted the Technical Support Engineer (TSE) and reported that errors 170 and 31089 were occurring. A new blue fiber cable had been opened, a power cycle had been performed, and the blue fiber cable had been reconnected prior to contacting support. At the time of the call, ports had been placed but the system had not yet been docked. Upon power up, neither blue cable port on the back of the Vision Side Cart (VSC) displayed blue LEDs. Due to a patient being on the table, the decision was made to bring in a different vision cart rather than continue swapping cables. The replacement vision cart was connected and the system powered on without errors for approximately three minutes before faulting again with the same 31089 errors. The backup blue fiber cable was then attempted, but the errors returned. A replacement Patient Side Cart (PSC) was subsequently obtained and connected alongside the replacement vision cart, while the original Surgeon Side Console (SSC)remained connected. The system was considered down. The procedure was converted to another DV system.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910824 ↗
• MalfunctionSep 26, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906717 ↗
• MalfunctionAug 22, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50389409 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242646 ↗
• MalfunctionAug 12, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224871 ↗
• InjuryAug 7, 2026Display or Visual Feedback Problem

  It was reported that during a da Vinci-assisted abdonimoperineal resection procedure, the operating room staff called Intuitive Surgical Inc. (ISI) Technical Support Engineers (TSE) to state the left eye image was split on both Surgeon Side Console (SSC) 1 and 2. The customer replaced the endoscope, but the issue remained. At the time of the call the customer was unable to power cycle the system due to active bleeding from the renal artery. It was reported that the bleeding from the renal artery started prior to the reported event; however, the split image on the left eye did cause it to take longer to suture the artery and stop the bleeding. The estimated blood loss was not provided; however, it was reported the patient received 3 units of blood and was admitted intubated to the Intensive Care Unit (ICU) post-operatively. After the bleeding was controlled a second call was made to ISI TSE and it was stated the staff was able to perform a hard power cycle to the system; however, the endoscope would not initiate. A second hard power cycle was performed, and an image was produced for a few moments before it was lost. TSE reviewed live system logs and saw an error from tower fiber por

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50175050 ↗
• MalfunctionJul 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092839 ↗
• MalfunctionJul 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092838 ↗
• MalfunctionMay 27, 2026No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, STAFF EXPERIENCED A VISION ISSUE IN THE RIGHT EYE OF THE SURGEON CONSOLE. TECHNICAL SUPPORT TROUBLESHOOTING FIRST INVOLVED CONFIRMING THE SITE DID NOT HAVE A BACKUP SCOPE AVAILABLE AND THAT THE SITE DID NOT WANT TO POWER CYCLE THE SYSTEM. TECHNICAL SUPPORT THEN HAD THE SITE REQUEST A BACKUP SCOPE FOR SWAP TESTING. AFTER ANOTHER SCOPE WAS TRIED, THE ISSUE REMAINED UNCHANGED, AND THE SITE PLANNED TO INSTALL THE BACKUP SCOPE ONCE IT ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25309029 ↗
• MalfunctionMay 12, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED SURGICAL PROCEDURE, THERE WAS A MESSAGE INDICATING THE CONSOLE WAS NOT CONNECTED. THE STAFF HAD ALREADY PERFORMED A HARD POWER CYCLE ONCE AND THE ERROR PERSISTED. TECHNICAL SUPPORT THEN INSTRUCTED A SECOND HARD POWER CYCLE, BUT THE ISSUE REMAINED AND ERROR 31089 WAS OBSERVED IN THE LOGS, INDICATING A PROBLEM WITH FIBER PORT 3 ON THE TOWER. TECHNICAL SUPPORT DIRECTED THE STAFF TO MOVE THE BLUE FIBER CABLE FROM PORT 3 TO ANOTHER PORT AND REBOOT THE SYSTEM, BUT THE ERROR STILL PERSISTED. THE STAFF PLANNED TO INFORM THE SURGEON AND HAD NOT YET DETERMINED HOW THEY WOULD PROCEED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155396 ↗
• MalfunctionMay 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE OPERATING ROOM STAFF ENCOUNTERED A "ROBOT NOT CONNECTED TO TOWER" MESSAGE AT THE START OF A PROCEDURE. LOGS WERE UNAVAILABLE AT THE TIME OF THE CALL. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO POWER DOWN THE SYSTEM. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SPECIFIC BLUE FIBER PORT ON THE TOWER CONNECTED TO THE ROBOT. THE TSE THEN GUIDED THE CUSTOMER TO RESEAT ALL BLUE CABLE CONNECTIONS, BUT THIS DID NOT RESOLVE THE ISSUE. THE TSE HAD THE CUSTOMER POWER UP THE PATIENT CART AND VISION TOWER IN STANDALONE MODE, AND BOTH COMPONENTS POWERED UP WITHOUT ERRORS. THE TSE INQUIRED IF A BACKUP BLUE FIBER CABLE WAS AVAILABLE, WHICH THE CUSTOMER CONFIRMED. THE TSE DIRECTED THE CUSTOMER TO REPLACE THE ROBOT'S BLUE FIBER CABLE AND CONNECT IT TO A DIFFERENT PORT ON THE TOWER. AFTER SWITCHING THE CONNECTION FROM TOWER BLUE FIBER PORT 3 TO PORT 2, THE SYSTEM BOOTED UP SUCCESSFULLY, ALLOWING THE STAFF TO PROCEED WITH THE CASE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118750 ↗
• MalfunctionApr 29, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ADVANCED PROCESSOR ERROR 66200 OCCURRED. THE CIRCULATING NURSE STATED THAT THE SURGEON UNDOCKED THE SYSTEM AND CONTINUED THE PROCEDURE WITHOUT THE ROBOT BEFORE CONTACTING TECHNICAL SUPPORT. BEFORE THE CALL, THE NURSE HAD ALREADY POWER CYCLED THE SYSTEM TWICE, BUT THE ERROR PERSISTED. AFTER REVIEWING THIS INFORMATION, TECHNICAL SUPPORT REQUESTED THAT THE ISSUE BE FURTHER TROUBLESHOT ONSITE, AND IT WAS NOTED THAT THE CUSTOMER DECLINED TO USE THE SYSTEM FOR SUBSEQUENT PROCEDURES. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC APPROACH WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029298 ↗
• MalfunctionApr 28, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NON-RECOVERABLE 40014 ERROR OCCURRING DURING SYSTEM STARTUP WHILE THE SYSTEM WAS CONFIGURED IN DUAL CONSOLE MODE. TECHNICAL SUPPORT HAD THE STAFF REMOVE ONE CONSOLE, AFTER WHICH THE SYSTEM STARTED SUCCESSFULLY AND COMPLETED SELF TEST. AT THE TIME OF TROUBLESHOOTING, THE SYSTEM REMAINED DISCONNECTED SO LOGS WERE NOT AVAILABLE, AND THE SYSTEM CONNECTION WAS REESTABLISHED SHORTLY AFTER THE CALL ENDED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022930 ↗
• MalfunctionApr 23, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961866 ↗
• MalfunctionApr 22, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT A RECURRING TOWER OVERHEATING MESSAGE. THE TSE HAD THE CALLER VERIFY THAT THERE WERE NO OBSTRUCTIONS IN FRONT OF THE TOWER, WHICH THE CALLER CONFIRMED, AND ALSO CONFIRMED THERE WAS NO VISIBLE DUST IN THE FRONT OF THE TOWER. THE TSE THEN RECOMMENDED THAT THE CUSTOMER POWER DOWN THE SYSTEM BETWEEN CASES TO ALLOW THE SYSTEM TO COOL OFF, AND THE CALLER AGREED TO INFORM THE STAFF BEFORE THE CALL ENDED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949115 ↗
• MalfunctionApr 21, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946577 ↗
• MalfunctionApr 21, 2026Unexpected Shutdown

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934406 ↗
• MalfunctionApr 20, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932752 ↗
• MalfunctionApr 20, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932741 ↗
• MalfunctionApr 20, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932740 ↗
• InjuryApr 20, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE CUSTOMER WAS ENCOUNTERING NON-RECOVERABLE SYSTEM ERRORS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE)) WAS UNABLE TO REVIEW THE SYSTEM LOGS SINCE THE SYSTEM WAS NOT CONNECTED TO THE INTERNET. BEFORE CALLING THE TSE FOR ASSISTANCE, THE CUSTOMER HAD ALREADY RESEATED ALL FIBER CABLE CONNECTIONS EXCEPT AT THE CONSOLE. THE TSE THEN GUIDED THE CUSTOMER TO POWER THE SYSTEM OFF AND RESEAT THE CONSOLE FIBER CABLE. AFTER THIS, THE SYSTEM POWERED BACK ON WITHOUT ERROR, AND THE CUSTOMER NOTED IT HAD PREVIOUSLY POWERED UP NORMALLY BEFORE FAILING AGAIN. THE TSE REMAINED ON THE LINE FOR SEVERAL MINUTES TO MONITOR WHETHER THE ERROR WOULD RECUR WHILE PORTS WERE BEING PLACED, DURING WHICH TIME THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGERY DUE TO FRUSTRATION WITH THE REPEATED ERROR. NO COMPLICATIONS TO THE PATIENT WERE REPORTED FOLLOWING THE CONVERSION TO OPEN SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24932105 ↗