da Vinci Xi 380721Recalls & reported problems

Summary

The FDA's MAUDE database contains 299 adverse event reports that list this exact device (DI 00886874115343), received between Aug 31, 2020 and Sep 29, 2026 — classified as 22 injuries, 277 malfunctions.

The most frequently reported specific device problem is “Output Problem” (115 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 20, 2022Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 299 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939481 ↗
• MalfunctionSep 26, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906735 ↗
• MalfunctionSep 25, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50905524 ↗
• MalfunctionSep 25, 2026No Device Output

  It was reported that during a da Vinci-assisted surgical procedure, the customer reported that the bottom monopolar port on the Integrated ElectroSurgical Unit (IESU) was not functioning, displaying a question mark when instruments were attached. Different instruments and energy cords were tested but the port still failed to recognize them. The top monopolar port remained functional. The Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) log review showed no related errors. The procedure was completed, and no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893636 ↗
• MalfunctionSep 24, 2026Unexpected Shutdown

  It was reported that during a da Vinci-assisted retroperitoneal anterior partial nephrectomy surgical procedure, an Intuitive Surgical (IS) Technical Support Engineer (TSE) was contacted for by the customer to report that the system shuts down by itself, mid procedure. As System was not OnSite connected, no logs were available, TSE asked customer to take pictures on the event logs in the touchscreen of the Vision Side Cart (VSC), but nothing received yet. No idea what triggered the shut down or on which Surgeon Side Console (SSC). A Field Service Engineer (FSE) would need to go on site to upload the logs so they can be analyzed to see what are the recommended actions. System was hard power cycled due to other problems. The procedure was completed with no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877566 ↗
• MalfunctionAug 13, 2026Output Problem

  It was reported that the user observed errors M-02 and C-00 when powering on the generator. The user restarted the unit only, but the same issue persisted. There was no report of patient involvement or patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243418 ↗
• MalfunctionAug 13, 2026Failure to Power Up

  Patient problems: Insufficient Information

  MAUDE report 50236932 ↗
• MalfunctionAug 12, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50229593 ↗
• InjuryAug 12, 2026Output Problem

  It was reported that during a da Vinci-assisted transvesical prostatectomy procedure, an error on the ERBE generator occurred during coagulation. Prior to calling an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE), the customer rebooted the ERBE generator, disconnected and reconnected the energy cables. The TSE inquired about the monopolar energy settings. The customer stated the monopolar energy was at level 3 with swift mode. The TSE asked what error codes were observed as the system was offline. The customer identified a possible error. The TSE asked the customer to switch to Classic mode, but the error persisted. The TSE advised the customer to shut down and unplug the ERBE generator, and wait 10 to 15 seconds before restarting the unit. After rebooting, two possibly related errors were observed. The TSE advised the customer to use a backup generator or another da Vinci system; however, the customer said there was no available backup. The customer elected to abort the procedure after ports had already been placed. The procedure was rescheduled and completed the next day. The patient is reported to be doing well.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50228451 ↗
• MalfunctionMay 28, 2026Difficult to Open or Close; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FAULT OCCURRED ON THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SITE REBOOTED THE SYSTEM AND ATTEMPTED TO USE A BACKUP GENERATOR, BUT THESE ACTIONS DID NOT RESOLVE THE ISSUE. THE STAFF INDICATED THEY WOULD USE ANOTHER SYSTEM INSTEAD AND ENDED THE CALL. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323902 ↗
• MalfunctionMay 18, 2026Output Problem

  IT WAS REPORTED THAT THE SITE CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REGARDING ISSUES WITH THEIR ERBE. HE STATED THAT THE ERBE WAS ISSUING C00 FAULTS. THE SYSTEM WAS RESTARTED, BUT THE SAME FAULT CONTINUED TO OCCUR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25210431 ↗
• MalfunctionMay 9, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR ENERGY IS NOT WORKING AND THE GENERATOR IS DISPLAYING ERROR CODE C34. TSE ADVISED CHANGING THE MONOPOLAR SETTINGS FROM SWIFT TO CLASSIC AS A TEMPORARY WORKAROUND HOWEVER THE ISSUE RETURNED. TECHNICAL SUPPORT ENGINEER (TSE) GUIDED CUSTOMER TO USE FORCE TRIAD AS WORKAROUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131718 ↗
• MalfunctionMay 7, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED AN ISSUE PREVIOUSLY IDENTIFIED HAD RETURNED, RESULTING IN THE SYSTEM PRESENTING NONRECOVERABLE FAULT 86. STAFF INDICATED THAT THIS FAULT OCCURRED EVEN AFTER HAVING WORKED WITH A TECHNICAL SUPPORT ENGINEER, AND THE SITE PLANNED TO USE A DIFFERENT VIDEO TOWER TO CONTINUE WITH THE PROCEDURE. NO TROUBLESHOOTING STEPS HAD BEEN COMPLETED INITIALLY. SUBSEQUENTLY, THE SYSTEM EXPERIENCED TWO NONRECOVERABLE FAULTS DURING A CASE, AND THE CUSTOMER PERFORMED A POWER CYCLE TO RECOVER AND CONTINUE. AFTER THE CALL ENDED, ERROR 86 APPEARED AGAIN AND WAS RELATED TO THE IPD. TROUBLESHOOTING STEPS HAD NOT BEEN FULLY COMPLETED, AND THE CUSTOMER WAS ADVISED TO CALL BACK IF THE ERROR RETURNED BEFORE ANOTHER POWER CYCLE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25117724 ↗
• MalfunctionApr 29, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VIO-DV GENERATOR HAD ERROR C-33 OCCURRED BEFORE SURGERY WHICH OCCURRED MULTIPLE TIMES RECENTLY. THE PROCEDURE WAS COMPLETING AS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 25030036 ↗
• MalfunctionApr 26, 2026Energy Output Problem

  IT WAS REPORTED THAT THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) HAD ISSUES WITH ACTIVATION/INTERMITTENT INSTRUMENT CONNECTIONS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24993939 ↗
• MalfunctionApr 24, 2026Unexpected Shutdown

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983446 ↗
• MalfunctionApr 24, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED INCISIONAL HERNIA IPOM SURGICAL PROCEDURE, THAT THE CUSTOMER EXPERIENCED A REPEATED NON RECOVERABLE FAULT 86 ON A VISION SIDE CART (VSC). BEFORE CONTACTING THE TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER HAD ALREADY CONVERTED TO A SECOND VSC TO CONTINUE THE SURGICAL PROCEDURE. TSE DISCUSSED THE EVENT WITH THE CUSTOMER BUT WAS NOT ABLE TO REVIEW LOGS OR DIRECTLY VERIFY THE REPORTED 86 ERROR AT THAT TIME. THE CUSTOMER CONTINUED THE PROCEDURE ON THE ALTERNATE VSC. THE PROCEDURE WAS CONVERTED TO ANOTHER DAVINCI SYSTEM WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975595 ↗
• MalfunctionApr 17, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA IPOM SURGICAL PROCEDURE, THE ERBE HAD REPEATED ERRORS COMING FROM THE SYSTEM. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ERRORS WERE FROM THE ERBE UNIT. ERROR C-83 HAD ERRORS WITHOUT ENERGY BEING APPLIED. THE TSE INFORMED THE CUSTOMER THAT THEY HAD THE OPTION TO USE A THIRD-PARTY GENERATOR WITH THE SYSTEM TO HOLD THEM OVER FOR THE DAY, SINCE THEY HAD MULTIPLE CASES LEFT FOR THE DAY. THE TSE EDUCATED THEM ON HOW TO SET UP THE THIRD-PARTY GENERATOR. THE CUSTOMER WAS NO LONGER RECEIVING ANY ERRORS AT THE MOMENT BUT WOULD USE IT IF NEEDED. THE ERBE HAD FAULTED AND GETTING C-82/C-83/C-84 ERRORS ON THE SCREEN, HOWEVER THE MONOPOLAR AND BIPOLAR ENERGY WAS WORKING INTERMITTENTLY. THE CUSTOMER TRIED NEW MONOPOLAR AND BIPOLAR ENERGY CORDS, TRIED PLUGGING INTO BOTH ENERGY PORTS ON THE ERBE BUT THE ISSUE REMAINED. THE LOGS CONFIRMED C-82/C-83/C-84 ERRORS. THE TSE RECOMMENDED TRYING TO REBOOT THE ERBE. THE CUSTOMER REBOOTED THE ERBE AND IT POWERED BACK ON, AND THE SURGEON TESTED THE ENERGY AND THE C-82 ERROR RETURNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915469 ↗
• MalfunctionApr 13, 2026Power Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866503 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE. THREE DAYS AFTER SURGERY, THE PATIENT EXPERIENCED FATIGUE FEVER/PYREXIA AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. THE EVENT WAS REPORTED AS RESOLVED AND DISCHARGE OCCURRED THREE DAYS LATER. THE INDEX PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND NO MALFUNCTION OF THE DA VINCI DEVICE, INSTRUMENTS OR ACCESSORIES. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, AND NOT RELATED TO THE DA VINCI STUDY DEVICE.

  Patient problems: Fatigue; Fever; Unspecified Infection

  MAUDE report 24836720 ↗
• MalfunctionApr 8, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE DUAL MONO FOOTPEDAL WAS DAMAGED AND HAD A BAD CONTACT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SINGLE-POLE PEDAL, WHICH IS AN ERBE COMPONENT, ACTIVATED BY ITSELF DUE TO FAULTY CONTACT. THE ISSUE OCCURRED AT THE END OF THE SURGERY WHILE STORING THE PEDAL. THE ISSUE WAS RESOLVED IN THE FOLLOWING SURGERIES BY USING A BACKUP MONOPOLAR PEDAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818460 ↗
• MalfunctionApr 3, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, A NURSE CALLED TO REPORT THAT THEY EXPERIENCED AN INTERMITTENT ISSUE WITH THE VESSEL SEALER AND BIPOLAR INSTRUMENTS EARLIER. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM EVENT LOGS BUT DID NOT OBSERVE ANY RELEVANT INFORMATION. THE CALLER SUSPECTED A POSSIBLE ISSUE WITH THE ERBE GENERATOR. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780839 ↗
• MalfunctionMar 30, 2026Power Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) HAD A BLANK SCREEN. BEFORE CONTACTING THE TSE, THE CUSTOMER REMOVED THE POWER CORD FROM THE IESU, CHANGED THE POWER OUTLETS AND TRIED A DIFFERENT POWER CABLE, BUT THE ISSUE PERSISTED. THE CUSTOMER DID NOT HAVE A SPARE EXTERNAL GENERATOR. THE CUSTOMER ELECTED TO SWAP THE VISION SIDE CART (VSC) TO CONTINUE WITH THE PROCEDURE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723093 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, ALL SYSTEM ARMS TURNED ON WITH RED LED LIGHTS WHEN SHUTTING DOWN THE SYSTEM AND ERROR CODE 40068 WAS DISPLAYED. THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CALLER TO PERFORM A HARD POWER CYCLE, BUT THE ISSUE DID NOT RESOLVE. ERROR 40068 OCCURRED EVERY TIME THE SYSTEM SHUT DOWN. THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE TSE CONFIRMED WITH THE CALLER THAT THE ETHERNET CABLE WAS CORRECTLY CONNECTED ON BOTH SIDES, WHICH WAS THE CASE. THE TSE GUIDED THE CALLER TO CHECK IF ONSITE INDICATIONS WERE PRESENT ON THE VISION SIDE CART (VSC) SETTINGS, WHICH WAS NOT THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710101 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709945 ↗