da Vinci Xi 380723Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00886874115374), received between Jun 3, 2020 and Sep 25, 2026 — classified as 14 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (49 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. Sep 20, 2022Open, Classified

   Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

   Z-0133-2023 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: Insufficient Information

  MAUDE report 50904522 ↗
• MalfunctionSep 24, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891143 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear; Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50231339 ↗
• MalfunctionAug 13, 2026No Display/Image

  Patient problems: Insufficient Information

  MAUDE report 50231290 ↗
• MalfunctionAug 12, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228051 ↗
• MalfunctionAug 11, 2026No Display/Image

  It was reported that prior to starting a da Vinci-assisted surgical procedure using a Xi system, an Operating Room (OR) staff called in to report that the Right High Resolution Stereo Viewer (HRSV-R) on the Surgeon Side Console (SSC) was black during case setup. The Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) walked the customer through a hard power cycle, but there was no change. As a result, the surgeon elected to abort to another dV system. Upon review, the TSE found error 121 on SSC 2, pointing to a suspect right eye HRSV monitor. No known impact or patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216606 ↗
• MalfunctionAug 8, 2026Connection Problem

  It was reported that prior to starting in a da Vinci-assisted surgical procedure, no ports placed, the customer identified Vision Side Cart (VSC) did not progress self-test and Surgeon Side Console (SSC) displayed message not connected to Vision Side Cart (VSC). Technical Support Engineer (TSE) observed recoverable error message/fault 31016, pointing at SSC being at different software level than VSC. The customer elected to swap SSC available on site to continue with the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50185201 ↗
• MalfunctionJul 28, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50062208 ↗
• MalfunctionMay 22, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A LOSS OF VIDEO ON THE LEFT SIDE DISPLAY OF THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) WAS OBSERVED. THE CALLER STATED THAT ALL WIRING AND CABLES HAD BEEN CHECKED AND NOTHING APPEARED DAMAGED OR DISCONNECTED. IT WAS ALSO NOTED THAT THE SYSTEM MONITORS CONTINUOUSLY DISPLAYED A SELF-TEST IN PROGRESS PLEASE WAIT MESSAGE. NO FURTHER INFORMATION WAS PROVIDED. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260810 ↗
• MalfunctionMay 18, 2026Visual Prompts will not Clear; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED TO REPORT REPEATED FAULTS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM), SPECIFICALLY A 25521 ERROR, WHICH PREVENTED ONE OF THE SURGEONS FROM CONTROLLING ARM 4. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED AND CONFIRMED THE 25521 ERROR RELATED TO THE RIGHT MASTER TOOL MANIPULATOR (MTM) AND VERIFIED THAT THE SITE HAD DISABLED MTM. THE TSE ADVISED THE CUSTOMER THAT THE MAIN SURGEON COULD SWITCH TO THE OTHER SURGEON SIDE CONSOLE (SSC) TO CONTROL USM 4 WITHOUT ISSUES. THE CUSTOMER CONFIRMED THAT THE OTHER SURGEON WAS ABLE TO CONTROL THE ARM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197055 ↗
• MalfunctionMay 9, 2026Failure to Sense

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE PROCEDURE STARTED AS A DUAL SURGEON SIDE CONSOLE (SSC) SYSTEM AND ONE OF THE SYSTEM VIEWERS ON THE FIRST CONSOLE WAS NOT MOVING, AND THAT THIS SAME BEHAVIOR HAD OCCURRED ON A PRIOR DAY. TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THAT THERE WERE NO PHYSICAL OBSTRUCTIONS PREVENTING MOVEMENT, WHICH THE CUSTOMER VERIFIED. THE SYSTEM WAS CONFIGURED AS A DUAL-CONSOLE, AND THE SURGEON WAS ACTIVELY USING THE OTHER CONSOLE. TSE INSTRUCTED THAT A FULL HARD POWER CYCLE OF THE AFFECTED CONSOLE BE PERFORMED AFTER THE PROCEDURE TO ADDRESS THE NONMOVING VIEWER. THE PROCEDURE WAS COMPLETED AS A SINGLE CONSOLE SYSTEM WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE SURGEON SIDE CONSOLE (SSC) IN QUESTION WAS A TEACHING SSC AND THEY COULD NOT MANUALLY MANIPULATE IT TO SEE COMFORTABLY.

  Patient problems: Insufficient Information

  MAUDE report 25131906 ↗
• MalfunctionMay 1, 2026Battery Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ROBOT IS SHOWING ERROR 819. ROBOT WAS THE ONLY PART OF THE SYSTEM IN THE OPERATING ROOM AT THE TIME OF THE CALL SO LIVE STATUS WAS NOT WORKING IN ARTEMIS. TECHNICAL SUPPORT ENGINEER (TSE) HAD NURSE MOVE THE ROBOT AND PLUG IT INTO A DIFFERENT OUTLET, ERROR 824 APPEARED. TSE THEN NURSE HARD POWER CYCLE THE SYSTEM, ERROR 824 CONTINUED. PER THE NURSE, THE BATTERY LED IS SHOWING 1 RED SOLID LIGHT. TSE HAD NURSE UNPLUG THE ROBOT FROM THE WALL AND THE ROBOT INSTANTLY SHUT OFF. TSE ADVISED NURSE TO KEEP THE ROBOT PLUGGED IN FOR THE NEXT COUPLE TO SEE IF CHARGING RESUMES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25054150 ↗
• MalfunctionApr 22, 2026Vibration

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949144 ↗
• MalfunctionApr 21, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE SURGEON SIDE CONSOLE'S (SSC) RIGHT MASTER TOOL MANIPULATOR (MTMR) EXPERIENCED A FAULT, AND ERROR CODE 23025 OCCURRED, DISABLING THE RMTM. THE CUSTOMER PERFORMED A HARD POWER CYCLE; HOWEVER, THE ISSUE REOCCURRED. AFTER POWERING ON THE COMPLETE SYSTEM, THE ISSUE WAS OCCURRING AGAIN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946076 ↗
• MalfunctionApr 15, 2026Vibration

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION AND HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THAT THE CUSTOMER CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) TO REPORT NOISE COMING FROM THE MASTER TOOL MANIPULATOR LEFT (MTML). THE CUSTOMER HAD RESTARTED THE DA VINCI SYSTEM BUT THE REPORTED COMPLAINT PERSISTED. TO COMPLETE THE SURGERY, THE CUSTOMER USED A SURGEON SIDE CONSOLE FROM ANOTHER DA VINCI SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880765 ↗
• MalfunctionApr 13, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM FAULTED AT THE END OF THE FIRST PROCEDURE OF THE DAY WHEN MOVING THE PATIENT SIDE CART (PSC) AWAY FROM THE BED. TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMER PERFORM HARD POWER CYCLE AND VERIFY BLUE FIBER CABLE CONNECTIONS, BUT SYSTEM KEPT POWERING ON WITH ERROR 23. TSE LOG REVIEW SHOWED ERRORS REPORTING FROM THE LEFT MASTER TOOL MANIPULATOR (MTML) ARMNET. CUSTOMER WILL BE MOVING PROCEDURE TO OTHER DAVINCI SYSTEM ON SITE. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24866675 ↗
• MalfunctionApr 13, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE RIGHT MASTER TOOL MANIPULATOR (MTM) DROPPED ON ITS OWN. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 23075, INDICATING THE RIGHT MTM DRIFTED. THE SUSPECT MTM WAS CONTROLLING UNIVERSAL SURGICAL MANIPULATOR (USM) 3, WHICH HAD A LARGE NEEDLE DRIVER INSTRUMENT INSTALLED. THE INSTRUMENTS WERE SWAPPED BETWEEN USMS 1 AND 3 AND THE ISSUE REMAINED. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE CUSTOMER WAS ABLE TO CONTINUE THE PROCEDURE ROBOTICALLY, EXPERIENCING DIFFICULTY WITH THE RIGHT MTM. THE DOCTOR COULD FEEL THE EFFECT OF THIS ISSUE ON THEIR OWN WRIST. THE CUSTOMER COMPLETED THE PROCEDURE USING ALL 4 USMS. THERE WAS A SURGICAL DELAY OF 15-20 MINUTES. THE MTMR WAS REPLACED. EVERYTHING WAS WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865428 ↗
• MalfunctionApr 8, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THAT THE RIGHT MASTER TOOL MANIPULATOR (MTM) WAS DROPPING DURING CLINICAL USE, AND ERROR 23075 WAS DETECTED, INDICATING RIGHT MTM DRIFT. THE SYSTEM WAS CONFIGURED WITH FOUR UNIVERSAL SURGICAL MANIPULATOR (USM) ARMS, AND THE ISSUE PERSISTED WITH THE SECONDARY INSTRUMENT ON THE USM 3. THE INSTRUMENTS WERE SWAPPED BETWEEN USM ARMS, BUT THE PROBLEM REMAINED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE CUSTOMER, THE TOTAL DELAY EXPERIENCED WAS APPROXIMATELY 40 MINUTES, AND THE OPERATIVE TIME FOR THE SURGICAL PROCEDURE WAS ABOUT 4 HOURS. IT WAS CONFIRMED THAT THERE WERE NO DATA (ND) INDICATING ANY INTRA OR POST-OPERATIVE COMPLICATIONS DUE TO THE DELAY. FURTHERMORE, THE SURGEON DID NOT REPORT ANY IMPACT ON THE PROCEDURE OR THE PATIENT¿S HEALTH AS A RESULT OF THE EVENT, NOR WERE THERE ANY CONCERNS EXPRESSED REGARDING LONG-TERM COMPLICATIONS ARISING FROM THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815788 ↗
• MalfunctionApr 3, 2026Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE AND PRIOR TO PORTS PLACEMENT, THE SURGEON SIDE CONSOLE (SSC) WOULD NOT POWER ON, AND THE SYSTEM INDICATED THAT THE SSC WAS NOT CONNECTED. THE CUSTOMER CHECKED THE BREAKER SWITCH AND OUTLET, AND THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO FLIP THE BREAKER AND ENSURE THE CABLE WAS FULLY SEATED INTO THE WALL OUTLET. DESPITE FLIPPING THE BREAKER TO THE ON POSITION, THE CONSOLE STILL WOULD NOT POWER ON. THE CUSTOMER NOTED THAT ANOTHER PIECE OF EQUIPMENT IN THE SAME OUTLET WAS RECEIVING POWER AND TRIED ANOTHER OUTLET WITH NO CHANGE. THE CUSTOMER STATED THAT ANOTHER PATIENT SIDE CART (PSC) WAS NOT AVAILABLE. THE CUSTOMER PROCEEDED WITH THE CASE LAPAROSCOPICALLY.

  Patient problems: Insufficient Information

  MAUDE report 24783891 ↗
• MalfunctionApr 3, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780963 ↗
• MalfunctionApr 2, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE USING AN XI SYSTEM, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE SYSTEM WERE FAULTING OUT. THE TSE REVIEWED THE SYSTEM LOGS AND IDENTIFIED AN ISSUE WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) GIMBAL. THE USER DID NOT WISH TO TROUBLESHOOT AT THAT TIME. LATER, THE ISSUE RETURNED, AND THE TSE NOTED ERROR 23017 ON THE MTML. THE USER ATTEMPTED TO RECOVER THE FAULT WITHOUT SUCCESS AND DECIDED TO CONVERT THE CASE TO A TRADITIONAL LAPAROSCOPIC APPROACH. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24771184 ↗
• MalfunctionApr 2, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24770860 ↗
• InjuryMar 31, 2026Display or Visual Feedback Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24743432 ↗
• MalfunctionMar 30, 2026Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE SURGEON SIDE CONSOLE (SSC) WAS OFF AND WOULD NOT POWER ON, DESPITE THE POWER BREAKER BEING SET TO ON. A MESSAGE INDICATED THAT THE SSC WAS NOT CONNECTED TO THE SYSTEM, ALTHOUGH THE VISION SIDE CART (VSC) AND PATIENT SIDE CART (PSC) WERE POWERED ON. SURGEON HAD PREVIOUSLY ATTEMPTED TO RESTART THE SYSTEM AND RESEAT THE BLUE FIBER CABLES WITHOUT SUCCESS. THE TSE CONFIRMED THE SSC WAS NOT CONNECTED AND GUIDED SITE TO TRY A DIFFERENT POWER SOCKET AND CHECK THE POWER CORD FOR DAMAGE, WHICH APPEARED FINE. DESPITE LEAVING THE SSC BREAKER OFF FOR A MINUTE AND TURNING IT BACK ON, THE ISSUE PERSISTED. SURGEON COULD HEAR A FAN RUNNING INSIDE THE SSC, BUT THE TOUCHPAD REMAINED BLACK AND THE POWER BUTTON WAS NOT LIT. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722660 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, ERROR 48200 OCCURRED AND THE LEFT EYE ON THE SURGEON SIDE CONSOLE (SSC) WAS DARK. CUSTOMER TRIED BOTH A POWER CYCLE AND A HARD CYCLE, BUT THE ISSUE PERSISTED. TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THAT ERROR 48200 POINTED TO THE PERSONALITY MODULE SURGEON CONSOLE (PMSC). TSE ADVISED CUSTOMER TO CHANGE THE CONSOLE, AND THIS RESOLVED THE ISSUE. TSE EXPLAINED TO CUSTOMER THAT SSC REQUIRED REPAIR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722494 ↗