da Vinci SP 380940Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00886874114735), received between Apr 3, 2022 and Sep 29, 2026 — classified as 1 death, 6 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (15 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939505 ↗
• MalfunctionAug 11, 2026No Display/Image

  Patient problems: Insufficient Information

  MAUDE report 50216733 ↗
• InjuryAug 6, 2026Human-Device Interface Problem

  It was reported that prior to starting a da Vinci-assisted procedure, post-anesthesia and after port placement, the customer reported the foot tray did not lower when the brake was pressed. Multiple system power cycles were attempted, but the issue persisted. While troubleshooting was ongoing, the surgeon elected to convert the case to laparoscopic surgery. An obstacle was then identified underneath the foot tray; once the obstruction was removed, the foot tray function returned to normal. The laparoscopic procedure was completed without further issue. The customer stated ports had already been placed, and docking and instrument installation were completed before the issue was identified. The procedure was converted to a laparoscopic approach because the surgery had been delayed due to the weekend schedule and there was pressure from the anesthesia team to proceed efficiently. Following conversion, one additional port was placed in addition to the existing ports. The surgeon had informed the patient preoperatively that conversion to video-assisted thoracoscopic surgery (VATS) might be necessary, as this was the surgeon¿s first case with the single port (SP) system, and the patient

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50155556 ↗
• MalfunctionAug 5, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50149755 ↗
• MalfunctionJul 29, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50064841 ↗
• MalfunctionMay 31, 2026Output Problem

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM THE SYSTEM ENCOUNTERED REPEATED ERROR #23009 OCCURRED ON THE MASTER TOOL MANIPULATOR RIGHT (MTMR). THE TEAM PERFORMED A HARD POWER-CYCLE FIRST, BUT IT DID NOT RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25341522 ↗
• MalfunctionMay 6, 2026Failure to Sense

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE SYSTEM THE SURGEON WAS NOT ABLE TO ACTIVATE FINGER CLUTCH OF THE MASTER TOOL MANIPULATOR (MTMR). THERE IS MESSAGE "HAND CONTROL SWITCHES BEEN DISABLED BY SYSTEM". EXPLAINED TO CUSTOMER THAT SURGEON IS ABLE TO USE FOOT PEDAL CLUTCH. ADVISED CUSTOMER TO VERIFY THAT FINGER CLUTCH IS WORKING FINE AFTER POWER CYCLE OF SYSTEM. THE PROCEDURE CONTINUED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090297 ↗
• MalfunctionApr 21, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM THERE WERE LINES GOING ACROSS THE SCREEN IN THE SURGEON SIDE CONSOLE (SSC) AND THAT THIS WAS AN ONGOING ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24946574 ↗
• MalfunctionApr 15, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE GRAVITY COMPENSATION ON BOTH SURGEON SIDE CONSOLES (SSC) WAS NOT FUNCTIONING AS EXPECTED. THIS ISSUE WAS OBSERVED BY BOTH THE CUSTOMER. THE SYSTEM WAS RESTARTED SEVERAL TIMES, BUT THE PROBLEM PERSISTED WITHOUT ANY ERROR CODES BEING DISPLAYED. ALTHOUGH THE SURGEONS WERE ABLE TO CONTINUE WORKING WITH THE SYSTEM, THEY EXPRESSED A DESIRE TO HAVE THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24886836 ↗
• MalfunctionApr 13, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE MASTER TOOL MANIPULATOR (MTM) WAS MOVING ON ITS OWN. THE CUSTOMER CONFIRMED THERE WERE NO ISSUES WITH THIS BEFORE OR AFTER THE COMPLAINT. THE SYSTEM LOGS FOUND A SINGULAR MASTER TOOL MANIPULATOR RIGHT (MTMR) DRIFTING EVENT ERROR 23100 ON DAY STATED. THE PROCEDURE WAS UNKNOWN HOW IT WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24866106 ↗
• MalfunctionApr 13, 2026Unintended System Motion

  IT WAS REPORTED THAT A CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER THAT THE MASTER TOOL MANIPULATOR (MTM) WAS DRIFTING DURING HEAD-OUT FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV). NO INFORMATION WAS PROVIDED ABOUT WHICH MTM WAS AFFECTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. ISI CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE. THE OPERATION WAS FINISHED ROBOTICALLY WITH NO CONVERSION OR ADDITIONAL PORTS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865120 ↗
• MalfunctionApr 11, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE GRAVITY COMPENSATION ON BOTH SURGEON SIDE CONSOLES (SSC) WAS NOT FUNCTIONING AS EXPECTED. THE SYSTEM WAS RESTARTED SEVERAL TIMES, BUT THE PROBLEM PERSISTED WITHOUT ANY ERROR CODES BEING DISPLAYED. ALTHOUGH THE SURGEONS WERE ABLE TO CONTINUE WORKING WITH THE SYSTEM, THEY EXPRESSED A DESIRE TO HAVE THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE TECHNICAL SERVICE ENGINEER, THE MASTER TOOL MANIPULATOR WAS BEING PULLED DOWN BY GRAVITY, AND THE GRAVITY COMPENSATION WAS APPLIED AND WAS DRIFTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851015 ↗
• MalfunctionApr 3, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY W/O LYMPHADENECTOMY SURGICAL PROCEDURE, THE SURGEON LOST FUNCTION OF THE ENDOSCOPE HOWEVER MAINTAINED VIDEO, BUT THE SURGEON WAS NOT ABLE TO MOVE THE CAMERA AT ALL. THE CUSTOMER POWER CYCLED THE SYSTEM WITH NO CHANGE AND WAS IN THE PROCESS OF PERFORMING A HARD REBOOT ON THE SYSTEM WHEN THE CALL STARTED. THE SYSTEM REBOOTED AND THE SURGEON WAS NOT ABLE TO TAKE CONTROL OF ANY OF THE ARMS AND NOTED THAT THE FOOT PEDALS WERE ALSO NON-RESPONSIVE. THE CUSTOMER CONFIRMED NO ERROR MESSAGES, NO FLASHING ARM LEDS, AND THE SURGEON'S HEAD WAS FULLY IN THE VIEWER. TECHNICAL SUPPORT ENGINEER (TSE) WAS UNABLE TO VIEW SYSTEM LOGS DURING THE CALL. TSE RECOMMENDED REPLACING THE DRAPE. AT THAT TIME, THE CUSTOMER ADVISED THAT EVERYTHING STARTED WORKING NORMALLY. TSE REMAINED ON THE LINE UNTIL THE CUSTOMER WAS COMFORTABLE PROCEEDING. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780218 ↗
• MalfunctionMar 30, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE SYSTEM HAD A FAULTY LIMIT SWITCH. THE ACTUATOR IN THE COLUMN WAS MOVING WHEN THE HIGH-RESOLUTION STEREO VIEWER (HRSV) HIT ITS LIMIT AND THERE WAS ALSO A SCREECHING SOUND. THE VALUES FOR THE ARMREST WERE NOT MOVING AND THE LIMIT SWITCH WAS "OPEN" EVEN WHEN THE ARMREST WAS AT THE LOWEST POSITION, INDICATING A BAD LIMIT SWITCH. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710163 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CALLER REPORTED ERROR 41103 POINTING TO MASTER TOOL MANIPULATOR RIGHT (MTMR). THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS, ERROR VERIFIED. TSE ASKED THE CALLER TO REBOOT THE SYSTEM AND CHECK IF MTMR WAS FREE TO MOVE. ERROR WAS ALWAYS PRESENT, SURGERY WAS NOT DONE WITH DAVINCI. THE PROCEDURE WAS ABORTED WITH NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709898 ↗
• MalfunctionMar 26, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE ERRORS IN THE SINGLE-PORT ONE AXIS MANIPULATOR CONTROLLER BOARD (SOAM). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708355 ↗
• MalfunctionMar 26, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT RECOVERABLE ERROR 23013 OCCURRED AGAINST THE LEFT MASTER TOOL MANIPULATOR (MTM). THE PORTS HAD NOT BEEN PLACED IN THE PATIENT WHEN THE ISSUE OCCURRED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND SEVERAL 23013 AND 23008 ERRORS AGAINST AXIS 1 OF THE LEFT MTM. THE TSE INSTRUCTED THE CALLER TO REBOOT THE SYSTEM USING THE EMERGENCY POWER OFF FUNCTION. THE ISSUE PERSISTED AND IT WAS NOT POSSIBLE TO RECOVER THE FAULT. THE SURGEON DECIDED TO ABORT THE PROCEDURE TO A DIFFERENT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 24707148 ↗
• MalfunctionMar 25, 2026No Display/Image

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, DURING SETUP TO REPORT THAT HE IS NOT SEEING AN IMAGE IN THE CONSOLE RIGHT EYE. SITE POWER CYCLED AND HARD POWER CYCLED THE CONSOLE. TECHNICAL SUPPORT ENGINEER (TSE) WALKED CALLER THROUGH AN ADDITION POWER CYCLE AND HARD POWER CYCLE OF THE CONSOLE AND THE TOWER. TSE ALSO HAD CALLER VERIFY FIBER CABLE CONNECTIONS BETWEEN TOWER AND CONSOLE. CALLER POWERED SYSTEM BACK ON AND AGAIN, THE RIGHT EYE HAD NO IMAGE. TSE THEN HAD CALLER POWER CONSOLE UP IN STAND-ALONE HOWEVER THE CONSOLE RIGHT EYE WAS STILL NOT PRESENT. TSE SUGGESTED HARD POWER CYCLING THE CONSOLE MULTIPLE TIMES. SITE CONVERTED TO ANOTHER DV SYSTEM. FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED PORTS WERE NOT PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM (XI) AND DVSTAT CONTACTED PRIOR TO ABORTING/CONVERTING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694534 ↗
• MalfunctionMar 25, 2026Output Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTRICAL SURGICAL UNIT WAS REPLACED DUE TO ERRORS C-87 AND M-31 IN THE SYSTEM LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP WAS PERFORMED WITH THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION. THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE SYSTEM RETURNED TO NORMAL AFTER THE GENERATOR WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693757 ↗
• MalfunctionMar 25, 2026No Display/Image

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE LEFT-EYE DISPLAY WAS NOT FUNCTIONING AT THE SURGEON SIDE CONSOLE (SSC). TECHNICAL SUPPORT ENGINEER (TSE) GUIDED CLINICAL SALES REPRESENTATIVE (CSR) AND CUSTOMER THROUGH PERFORMING A HARD POWER CYCLE AND CLEANING AND RESEATING ALL BLUE FIBER CABLES; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693692 ↗
• MalfunctionMar 25, 2026Output Problem

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE CUSTOMER WAS ENCOUNTERING REPEATED NON-RECOVERABLE 307 ERRORS ON STARTUP POINTING TO THE LEFT MASTER TOOL MANIPULATOR (MTML) ON THE SURGEON SIDE CONSOLE (SSC). THE STAFF HAD HARD POWER-CYCLED THE SSC WITH NO RESOLUTION. THE PROCEDURE WAS ABORTED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693644 ↗
• MalfunctionMar 19, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MASTER TOOL MANIPULATOR WAS DRIFTING. THE CUSTOMER CONFIRMED THAT THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE SYSTEM. THE CUSTOMER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM CONFIGURATION WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE INSTRUMENT WAS INSIDE THE PATIENT WHEN THE LEFT MASTER TOOL MANIPULATOR (MTML) DRIFTED. IT WAS ALSO STATED THAT THE SURGEON HAD REMOVED THEIR HANDS WHILE THEIR HEAD WAS STILL INSIDE THE SURGEON CONSOLE¿S HIGH-RESOLUTION STEREO VIEWER WHEN THE DRIFTING OCCURRED. NO ERRORS OCCUR AT THE TIME OF THE REPORT. THE ISSUE WAS PERSISTENT AFTER THE MTML GRAVITY COMPENSATION CALIBRATION, LEADING TO THE REPLACEMENT OF THE MTML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640973 ↗
• MalfunctionMar 9, 2026Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552332 ↗
• MalfunctionMar 9, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF A DA VINCI-ASSISTED SURGICAL SYSTEM, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MASTER TOOL MANIPULATOR RIGHT (MTMR) DUE TO THE MTM DRIFTING; HOWEVER, THE ISSUE REMAINED. THE TRAINING TEAM REQUESTED THE FSE TO INVESTIGATE THE MTMR DRIFTING ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24552255 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE USER ENCOUNTERED A GREEN SCREEN ISSUE DISPLAYED ONLY ON THE SURGEON SIDE CONSOLE'S HIGH RESOLUTION STEREO VIEWER (HRSV-L), WHILE THE VISION SIDE CART HAD NO ISSUES. THE USER CONDUCTED BOTH A POWER CYCLE AND A HARD POWER CYCLE OF THE SYSTEM, BUT THE ISSUE PERSISTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE ENTIRE SCREEN ON THE LEFT EYE WAS SOLID GREEN WITH NO VISIBLE IMAGE.

  Patient problems: Insufficient Information

  MAUDE report 24537812 ↗