daVinci Si 380675Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00886874110737), received between Jun 30, 2021 and Sep 22, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861010 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT 17. THE CUSTOMER SWAPPED OUT CABLES AND HARD POWER CYCLED THE SYSTEM BUT THE ERROR RETURNED. THE CUSTOMER ENDED THE CALL AND REQUESTED SERVICE ON THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710084 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START - PRE-ANESTHESIA OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT 90. CUSTOMER DID A SYSTEM HARD POWER CYCLE AND NORMAL POWER CYCLE MULTIPLE TIMES, BUT ISSUE REMAINED. TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED TO RESET CORE FROM THE BACK BUT ISSUE STILL REMAINED. TSE REVIEWED LOGS AND FOUND ISSUE WITH PATIENT CART CONTROLLER (PCC) AND GENERIC POWER DISTRIBUTOR (GPD) BOARD. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709910 ↗
• MalfunctionMar 2, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED ERROR 824 AND 861 POINTING TO THE BATTERY. THE CUSTOMER WAS ABLE TO RECOVER FROM THE ERROR. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491167 ↗
• MalfunctionFeb 6, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE PATIENT SIDE CART (PSC) WAS NOT POWERING ON. THE CUSTOMER TRIED TO POWER CYCLE THE SYSTEM BUT THE ISSUE REMAINED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284152 ↗
• MalfunctionJan 15, 2026Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077545 ↗
• MalfunctionMar 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT THERE WAS ERROR 22003 - WITH THE P-VALUES POINTING TO SUJX- AXIS-4. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO STARTING POST ANESTHESIA WITH PORTS PLACED AND THE PROCEDURE WAS COMPLETED WITH 3 ARMS DUE TO THE SET UP JOINT (SUJ) AXIS 4 ISSUE. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY AND WITH A DELAY OF LESS THAN 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704728 ↗
• MalfunctionJun 19, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THE PATIENT SIDE MANIPULATOR (PSM)3 WAS HAVING INSERTION MOVEMENT ISSUE. THE TSE REVIEWED LOGS AND CONFIRMED INFORMATIONAL ERROR 22023 ON PSM3 AXIS. THE CSR CONFIRMED POWER CYCLE AND DRAPE RESET WAS ALREADY DONE BUT IT DIDN'T WORK. THE FIELD SERVICE ENGINEER (FSE) WILL VISIT FOR FURTHER TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH THREE ARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569533 ↗
• InjuryMay 21, 2024Failure to Power Up; Failure to Power Up

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357218 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, THE ARM 1 CANNULA MOUNT PARTIALLY BROKE OFF AND ONE OF THE SCREWS WAS VISIBLE. IT WAS STATED THEY PUSHED ARM 1 OUT OF THE WAY AND PROCEEDED WITH THE CASE USING ARMS 2 & 3. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692315 ↗
• MalfunctionNov 17, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 1 AXIS3 WAS OBSERVED TO BE NOT MOVING AT ALL EVEN AFTER THE CLUTCH BUTTON WAS PRESSED. THE INTUITIVE TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO PERFORM AN EMERGENCY POWER OFF (EPO), BUT THE REPORTED COMPLAINT REMAINED. THE CUSTOMER CONFIRMED THAT THE PSM DID MOVE BUT DID NOT RETURN TO ITS ORIGINAL POSITION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY USING THREE UNIVERSAL SURGICAL MANIPULATORS (USMS). INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER COMPLETED THE PROCEDURE WITH 3 USMS AS THE ISSUE WAS NOT RESOLVED ON THE PSM 1. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164855 ↗
• MalfunctionJun 2, 2023Visual Prompts will not Clear; No Apparent Adverse Event; Visual Prompts will not Clear; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD RECOVERABLE FAULT OCCURRED AND THE CUSTOMER DISABLED THE ARM 3 AND COMPLETED THE PROCEDURE. ERRORS 23025, 23009, AND 23008 REPORTED IN REMOTEFE. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SUGGESTED FOR POWER CYCLE AND CUSTOMER WAS NOT READY TO RESTART THE SYSTEM. THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046360 ↗
• MalfunctionMay 5, 2023Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881740 ↗
• MalfunctionApr 27, 2023Visual 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 16821514 ↗
• MalfunctionJan 4, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD ILLUMINATOR ERROR FOR LAMP MODULE, THE SYSTEM POPS UP ERROR 48245 WHILE TURNING ON THE ILLUMINATOR. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE SYSTEM LOGS AND FOUND SAME ERROR REPORTED AND SORTED OUT BY RESETTING OF LAMP MODULE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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 ILLUMINATOR INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH BACK UP ILLUMINATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098889 ↗
• MalfunctionSep 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN INTUITIVE SURGICAL (IS) FIELD SERVICE ENGINEER (FSE) WAS CONTACTED FOR ASSISTANCE. SOME RESISTANCE IN ARM 2 WAS OBSERVED. LOGS WERE CLEAN BUT ACCORDING TO THE CUSTOMER THE ARM MADE UNUSUAL NOISE AND WANTED TROUBLESHOOTING FOR ARM 2. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THERE IS NO TRACEABLE INFORMATION ABOUT HOW LONG HAD THE SURGERY BEEN IN PROGRESS WHEN THE PROBLEM OCCURRED. THE SURGEON WAS ABLE TO SOLVE THE PROBLEM AFTER REBOOTING THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH 4 ARMS AND NO SPECIFIC INFORMATION ABOUT THE PROCEDURE DELAY HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474782 ↗
• MalfunctionSep 23, 2022Visual 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 15474657 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT REPORTEDLY SUFFERED FROM A POST-OPERATIVE AIR LEAK. ACCORDING TO THE SURGEON, THE AIR LEAK OCCURRED FROM THE BRONCHUS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE WAS DONE IN THE PRESENCE OF A PROCTOR. THE STAPLING WAS DONE BY AN ASSISTANT WITH A "COVIDIEN TRI-STAPLER." THE PATIENT WAS TAKEN BACK TO THE OR FOR RE-CLOSURE OF THE BRONCHIAL STUMP. THE PATIENT WENT TO THE ICU FOLLOWING SURGERY AS A PRECAUTION BECAUSE OF SIGNIFICANT COMORBIDITY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14229127 ↗
• MalfunctionMar 20, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A RECOVERABLE FAULT 23005 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING SUPPORT. TSE REVIEWED THE LOGS AND CONFIRMED ERROR 23005 POINTING TO USM 1. TSE REQUESTED CALLER TO USE THE INSTRUMENT (LARGE CLIP APPLIER) WHICH CAUSED THE PROBLEM ON A DIFFERENT ARM. CALLER STATED THAT THIS IS NOT POSSIBLE AT THE MOMENT. CALLER ALSO STATED THEY HAVE USED A DIFFERENT LARGE CLIP APPLIER WHICH HAD THE SAME PROBLEM ON ARM 1. TSE REQUESTED CALLER TO RESEAT ARM DRAPE AND STERILE ADAPTER (SA) ON ARM 1. CALLER STATED THIS IS ALSO NOT POSSIBLE AT THE MOMENT. TSE AGREED WITH CALLER TO TRY THE FOLLOWING WHEN THIS IS POSSIBLE DURING OR AFTER THE SURGERY: RESEAT THE SA ON ARM 1, USE THE INSTRUMENT ON A DIFFERENT ARM, POWER CYCLE AND EMERGENCY POWER OFF (EPO) THE SYSTEM. THE CALLER AGREED TO PERFORM THE STEPS AND CALL WITH THE RESULTS BACK AS SOON AS THIS IS DONE. CALLER CALLED BACK TO INFORM THAT PATIENT SIDE MANIPULATOR (PSM)1 IS DEFINITELY NOT WORKING. THEY RESEATED SA, POWER CYCLED SYSTEM WITH EPO AND TRIED OTHER INSTRUMENTS THAN CLIP A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13832832 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, SEVERE ADHESIONS WERE ENCOUNTERED DURING THE INFERIOR MESENTERY ARTERY (IMA) TREATMENT RESULTING IN INSUFFICIENT IDENTIFICATION OF THE ANATOMY. AS A RESULT, THE IMA WAS TORN DURING THE PROCEDURE, AND THE PATIENT EXPERIENCED BLEEDING. AT THAT TIME, THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY (OPEN PROCEDURE). THE SURGEON WAS ABLE TO CONTROL THE BLEEDING WITH SUTURES AND CONTINUE THE PROCEDURE WITHOUT MAJOR PROBLEMS AFTER CONVERTING TO AN OPEN SURGICAL PROCEDURE. THE SURGEON STATED THERE WAS NO ALLEGATION THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY DID NOT FUNCTION AS INTENDED. THE SURGEON INDICATED THAT THE BLEEDING RESULTED FROM AN INJURY OF THE IMA DUE TO THE DIFFICULTY OF ANATOMIC IDENTIFICATION, DUE TO THE SEVERE ADHESIONS. ON 05-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT THE FENESTRATED BIPOLAR INSTRUMENT WAS INSTALLED ON THE LEFT ARM, THE MONOPOLAR CURVED SCISSORS ON THE RIGHT ARM, AND THE DOUBLE FENESTRATED GRASPER INSTRUMENTS ON THE THIRD ARM. IT WAS UNSPECIF

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12694454 ↗
• MalfunctionJun 30, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT TO REPORT THAT THEY ENCOUNTERED A ¿PATIENT SIDE CART (PSC) RUNNING ON BATTERY¿ MESSAGE. THE CUSTOMER REPORTED THAT THE WALL POWER OUTLET HAD POWER BECAUSE THE OTHER EQUIPMENT WAS WORKING. THE CUSTOMER PERFORMED AN EMERGENCY POWER OFF (EPO) WITH NO SUCCESS. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER MOVE THE OUTLETS TO A DIFFERENT BREAKER, AND THE PSC WAS RUNNING ON ALTERNATING CURRENT (AC) POWER. THE SITE CONTINUED WITH THE CASE SETUP. THE CUSTOMER CALLED BACK IN WHILE THEY WERE DOCKED TO THE PATIENT TO REPORT THAT THE MESSAGE HAD RETURNED. THE TSE HAD THE CUSTOMER MOVE TO DIFFERENT WALL POWER OUTLETS, BUT THE ISSUE WAS NOT RESOLVED. THE TSE CONFIRMED WITH THE CUSTOMER THE WALL POWER OUTLET HAD POWER BY PLUGGING IN AN ENDOSCOPE WARMER. THE TSE HAD THE CUSTOMER POWER CYCLE THE SYSTEM, AND WHILE THEY WERE POWERING THE SYSTEM BACK DOWN, THE BATTERY LIGHT EMITTING DIODES (LEDS) ON THE HELM WERE FLASHING RED. THE CUSTOMER TRIED TO POWER THE SYSTEM BACK ON AFTER A HARD POWER CYCLE WAS PERFORMED ON THE PSC, BUT THE PSC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097069 ↗