daVinci Si 380689Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00886874110782), received between May 21, 2021 and Jul 1, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THE SURGEON SIDE CONSOLE (SSC) RIGHT SIDE HAD NO IMAGE. SITE INFORMED THAT THE VISION SIDE CART (VSC) SHOWED BOTH LEFT AND RIGHT IMAGE. TSE REVIEWED LIVE LOGS BUT DID NOT FIND ANY RELATED ERROR REGARDING THE ISSUE. THE CUSTOMER HARD POWER CYCLED BUT THE ISSUE WAS NOT RESOLVED. SITE WAS CONTINUING SURGERY USING 2D VISION. ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED BY THE SURGEON WAS ROBOTIC ABDOMINOPERINEAL RESECTION (APR). THE PROCEDURE TOOK PLACE AT 10:00 AM. IT WAS COMPLETED SUCCESSFULLY DESPITE THE ABSENCE OF AN IMAGE ON THE RIGHT SIDE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). REFER TO SECTION A FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368490 ↗
• InjuryMay 2, 2025Output Problem; Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21954604 ↗
• MalfunctionApr 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT RIGHT EYE VISION RESOLUTION WAS INCORRECT, AND THE TSE SUGGESTED HARD POWER CYCLE. THE ISSUE WAS NOT RESOLVED AFTER COUPLE OF HARD POWER CYCLE. THE RIGHT EYE VISION WAS COMPLETELY BLANK AND 45308 REPORTED EVERY POWER CYCLE. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922521 ↗
• MalfunctionMar 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS NON-RECOVERABLE FAULT 25326. THE TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED FOR REBOOT THE SYSTEM AFTER RESEATING THE BLUE FIBER CABLE (BFC) CONNECTIONS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO INDICATION OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. IT WAS UNKNOWN IF PORT INCISION SIZE WAS INCREASED, OR ADDITIONAL PORTS PLACED. INITIALLY THE CUSTOMER CONTACTED WHEN THE PROBLEM WAS REPEATED AGAIN, THEY DECIDED TO CONVERT THE PROCEDURE PRIOR TO CONTACTING ISI TECHNICAL SUPPORT. THERE WAS NO INDICATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713242 ↗
• MalfunctionSep 25, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE RIGHT EYE VISION WAS BLINKING. THE SITE WAS NOT ABLE TO REBOOT THE SYSTEM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305185 ↗
• MalfunctionSep 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE USER OBSERVED THAT THE SURGEON SIDE CONSOLE (SSC) HIGH-RESOLUTION STEREO VIEWER'S (HRSV) LEFT EYE WAS BLURRY. HOWEVER, THE IMAGES FROM BOTH THE RIGHT AND LEFT EYES ON THE VISION SIDE CART'S (VSC) TOUCHSCREEN WERE NORMAL. THE USER RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE USER WAS INSTRUCTED TO REBOOT AND RESEAT THE BLUE FIBER CABLE, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER DID NOT KNOW WHETHER PORT INCISIONS WERE INCREASED, OR ADDITIONAL PORTS WERE PLACED. THE REPORTER DID NOT KNOW WHETHER THE PATIENT TOLERATED THE CONVERSION. THE SYSTEM'S FUNCTIONALITY WAS CHECKED UPON POWERING THE SYSTEM AND NO ISSUES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197320 ↗
• MalfunctionJun 1, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE BIOMED CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THERE WAS A NON-RECOVERABLE FAULT. ERROR 5 WAS REPORTED FOR THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) FAN ON THE SURGEON BACKPLANE (SBP). THE TSE SUGGESTED THAT THE CUSTOMER HARD POWER CYCLE THE SURGEON SIDE CONSOLE (SSC). THE ISSUE WAS NOT RESOLVED AFTER A COUPLE OF RESTARTS. THE TSE INFORMED THE CUSTOMER THAT THE SYSTEM WAS DOWN. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE WITH NOTHING OUT OF THE ORDINARY NOTED. PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY BECAUSE THE SYSTEM WAS UNABLE TO RECOVER THE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442825 ↗
• MalfunctionOct 20, 2023Poor Quality Image; Poor Quality Image

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981195 ↗
• MalfunctionAug 22, 2023Failure to Sense; Failure to Sense

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597214 ↗
• MalfunctionJun 6, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ERROR 23017 OCCURRED POINTING TO THE LEFT MASTER TOOL MANIPULATOR (MTM). NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BEFORE THE REPORTED ERROR 23017 OCCURRED, THE SYSTEM POWERED-ON WITHOUT ANY ERRORS AND THE PORTS WERE ALREADY PLACED. THE SITE CONFIRMED THAT ISI'S TECHNICAL SUPPORT WAS NOT CONTACTED FOR TROUBLESHOOTING WHEN THE REPORTED ERROR OCCURRED. THE OPERATING ROOM (OR) TEAM CONSEQUENTLY DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORT OF PATIENT INJURY. AS A RESULT OF THE CONVERSION, THE PROCEDURE TOOK ONE (1) HOUR LONGER THAN INITIALLY PLANNED WITH THE DA VINCI SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067564 ↗
• MalfunctionJun 2, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE LEFT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE CUSTOMER STATED THAT THERE WERE TWO (2) CONSOLES IN THE ROOM, AND THERE WAS NO ISSUE WITH THE OTHER CONSOLE, WHERE THE SURGEON WAS WORKING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND THERE WERE NO ERRORS NOTED. THE TSE ADVISED THE CUSTOMER TO POWER-CYCLE THE SYSTEM. THE CUSTOMER STATED THAT THEY WERE GOING TO HAVE TO WAIT, AS THE SURGEON WAS PROCEEDING, "AS IS." THE TSE THEN RECOMMENDED TO THE CUSTOMER THAT WHEN THEY GET THE CHANCE, FOR THEM TO POWER-CYCLE THE SYSTEM AND CHECK BOTH EYES IN THE SUSPECT CONSOLE, TO CONFIRM BOTH WERE WORKING. THE CUSTOMER AGREED AND REQUESTED AN ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE CUSTOMER ALSO STATED THAT THE SUSPECT CONSOLE WAS THE ONE CLOSEST TO THE LIGHT SOURCE CONTROL BOX. THE CUSTOMER SITE PROCEEDED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17047436 ↗
• MalfunctionMay 22, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER DID NOT HAVE VISION IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DID NOT OBSERVE ANY SYSTEM LOG ISSUES RELATED TO REPORTED PROBLEM. THE CUSTOMER CONFIRMED THEY HAD LEFT AND RIGHT EYE VIDEO ON THE VISION SIDE CART (VSC). THE CUSTOMER PERFORMED A POWER-CYCLE OF THE SYSTEM AND A HARD POWER-CYCLE OF THE SSC. THE CUSTOMER THEN POWERED BACK UP WITH NO CHANGE AND CONFIRMED THEY STILL HAD LEFT AND RIGHT EYE VIDEO ON THE VSC. THE CUSTOMER PROCEEDED WITH AN ADDITIONAL POWER-CYCLE OF THE SYSTEM, A HARD POWER-CYCLE OF SSC, AND RESEATED THE BLUE FIBER CABLES DURING THE POWER-CYCLE. THE CUSTOMER POWERED THE SYSTEM BACK ON WITH NO CHANGE. THE CUSTOMER WAS UNSURE OF HOW THE SURGEON WAS GOING TO PROCEED. AN ISI FIELD SERVICE ENGINEER (FSE) WAS TO FOLLOW UP. THERE WAS NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED USING THE SAME SURGEON CONSOLE WITH NO PATIENT INJURY. THE SURGEON PUT AN EYE PATCH ON HER RIGHT EYE AND COMPLETED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971749 ↗
• MalfunctionJan 15, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED RECOVERABLE FAULT 23017. THE CUSTOMER WAS RECOVERING ERROR EACH TIME. THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16170355 ↗
• MalfunctionOct 27, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686595 ↗
• MalfunctionJun 3, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD NON A RECOVERABLE ERROR 17. THE CUSTOMER HAD POWER CYCLED THE SYSTEM. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE SYSTEM LOGS AND FOUND A COMMUNICATION ISSUE BETWEEN THE SURGEON SIDE CONSOLE (SSC) AND THE VISION SIDE CART (VSC). THE TSE ADVISED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM AND RESEAT THE BLUE FIBER CABLE TO BOTH ENDS, BUT THE ISSUE STILL PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 10-MAY-2022: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY DUE TO NON RECOVERABLE ERROR 17. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM WAS BOOTED UP PROPERLY. THE ISI FIELD SERVICE ENGINEER (FSE) REPLACED THE PARTS TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598914 ↗
• MalfunctionDec 14, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006742 ↗
• MalfunctionMay 21, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM ENCOUNTERED A NON-RECOVERABLE FAULT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 5 POINTING TO THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) ON THE SURGEON BACK PLANE (SBP). THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THE ISSUE HAPPENED DURING THE PROCEDURE WHEN ALL PORTS WERE PLACED. THERE WERE NO ISSUES WITH THE PORT PLACEMENT. ALL TROUBLESHOOTING STEPS WERE EXHAUSTED WITH NO RESOLUTION TO THE ISSUE. THERE WAS NO PATIENT INJURY. THE PATIENT DEMOGRAPHIC IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866430 ↗