daVinci Si 380610Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00886874110683), received between Apr 20, 2017 and Sep 30, 2026 — classified as 7 injuries, 123 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (43 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 16, 2018Terminated

   Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

   Z-3254-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953504 ↗
• MalfunctionMay 7, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RIGHT EYESIGHT OF THE HIGH RESOLUTION STEREO VIEWER (HRSV) IN THE SURGEON SIDE CONSOLE (SSC) WAS BLANK. TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM. CUSTOMER FOLLOWED AND REPLIED THE ISSUE HAD NO CHANGE. SURGEON WAS COMPLETING THE PROCEDURE WITH ONE EYE AND FIELD SERVICE ENGINEER (FSE) WILL FOLLOW UP THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118640 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TECHNICAL SUPPORT TO REPORT A NON-RECOVERABLE 31016 ERROR. THE CSR ADVISED THEY WERE TRYING TO CONNECT SURGEON SIDE CONSOLE (SSC) SN (B)(6) TO THE VISION SIDE CART (VSC) FOR SYSTEM SK2589. THE TECHNICAL SUPPORT ENGINEER (TSE) IDENTIFIED THAT THE SSC SHOWED AS AN SI CONSOLE. HOWEVER, THE CSR ADVISED THAT THE SSC HAS BEEN UPGRADED TO A XI CONSOLE. AS A RESULT, A FIELD SERVICE ORDER WAS INITIATED FOR FURTHER INVESTIGATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720747 ↗
• MalfunctionMar 4, 2026No Display/Image

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE SYSTEM WAS CHECKED AND ONE OF THE SURGEON CONSOLE'S (SSC) HIGH RESOLUTION STEREO VIEWER'S (HRSV) EYES HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED VIA POWER CYCLE; HOWEVER, THE ISSUE PERSISTED. THE PLANNED PROCEDURE WAS ABORTED. NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24508114 ↗
• MalfunctionNov 22, 2025Material Integrity Problem; Material Integrity Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625077 ↗
• MalfunctionAug 7, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM2) WAS OUT OF CONTROL AND COULD NOT OPEN AND CLOSE SUDDENLY. THE CUSTOMER POWER CYCLED THE SYSTEM HOWEVER THE ISSUE WAS UNABLE TO BE FIXED. DUE TO PROCEDURE WAS ONGOING, THE CUSTOMER USED PSM3 TO CONTINUE PROCEDURE. THE SYSTEM HAD NO ERROR REPORTED AND CUSTOMER FOUND A COMPONENT NEAR THE PATIENT SIDE CART (PSC) WHICH WAS DOUBTED IF IT HAD FALLEN OFF THE PSM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743395 ↗
• MalfunctionJul 31, 2025Optical Problem; Optical Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681456 ↗
• MalfunctionJul 23, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MASTER TOOL MANIPULATOR (MTM) HAD NON-INTUITIVE MOTION WHICH WAS INTERMITTENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER REPLACED ANOTHER "SOCKET" TO RESOLVE THIS ISSUE. THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY WITH THE ORIGINAL CONFIGURATION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583921 ↗
• MalfunctionJul 11, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485989 ↗
• MalfunctionJul 2, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379930 ↗
• MalfunctionJun 23, 2025Unexpected Shutdown; Unexpected Shutdown

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311364 ↗
• MalfunctionMay 19, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INDICATED THAT THE LEFT MASTER TOOL MANIPULATOR (MTML) WAS DRIFTING AND NOT WORKING PROPERLY. THE PROCEDURE WAS CONVERTED TO ANOTHER DV WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT THE ISSUE WAS RESOLVED AUTOMATICALLY AFTER 3-5 MINS. THE INSTRUMENT WAS IN PATIENT AT THE TIME OF THE EVENT. THE MOTION ISSUE DUE TO MTM DRIFT DID NOT OCCUR WHEN SURGEON REMOVED HANDS FROM MTM WHILE HEAD STILL IN VIEWER. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046613 ↗
• MalfunctionJan 23, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETEROURETEROSTOMY SURGICAL PROCEDURE, THE SURGEON SIDE CART (SSC) HIGH-RESOLUTION STEREO VIEWER (HRSV) RIGHT SIDE HAD NO VIDEO. THE TECHNICAL SERVICE ENGINEER (TSE) GUIDED SITE TO REPLACE THE BACKUP ENDOSCOPE AND HARD POWER CYCLE THE SYSTEM. THEN TSE GUIDED SITE TO RESEAT THE BLUE FIBER. ALSO, TSE SUGGESTED SITE TO SET THE 3D MODE TO 2D MODE. HOWEVER, THE ISSUE WAS NOT RESOLVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE SYSTEM POWERED ON WITH NO ERRORS AND WAS FUNCTIONAL. THE SYSTEM WAS HARD POWERED CYCLED, AND THE ENDOSCOPE WAS REPLACED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH ORIGINAL CONFIGURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215713 ↗
• MalfunctionJan 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121074 ↗
• MalfunctionJan 6, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077977 ↗
• MalfunctionDec 11, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL W/O LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SURGEON SIDE CONSOLE (SSC) WAS OBSERVED TO HAVE A LOST RIGHT IMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ANOTHER SURGEON SIDE CONSOLE (SSC) WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903820 ↗
• MalfunctionNov 25, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) LEFT EYE WAS BLACK AND HAD RECONNECTED CAMERA CABLES THREE TIMES WITHOUT SUCCESS. SITE ALSO RESEATED BLUE FIBER CABLE (BFC), BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED IF THE CUSTOMER WAS ABLE TO SEE LEFT EYE ON VISION SIDE CART (VSC) TOUCHSCREEN AND THAT WAS THE CASE AND GUIDED CALLER TO POWER THE SYSTEM OFF, RECONNECTING BFC ON SSC, AND POWER THE SYSTEM BACK ON. THE TSE SAID THE CUSTOMER SHOULD CHECK WHETHER THE DA VINCI LOGO WAS PRESENT ON SSC LEFT EYE DURING POWER ON SEQUENCE, HOWEVER, LEFT EYE WAS COMPLETELY BLACK DURING THE WHOLE PROCESS. THE TSE THEN GUIDED CALLER TO POWER CYCLE THE SYSTEM AGAIN, UNPLUGGING SSC WHILE IT WAS OFF, WITH SAME RESULT. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS A PROCEDURE DELAY BETWEEN 15-30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769976 ↗
• MalfunctionOct 18, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488098 ↗
• MalfunctionOct 4, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE INSTRUMENT DID NOT STOP MOVING WHEN USING THE FINGER CLUTCH FUNCTION. THERE WAS NO ERROR REPORTED. THE CUSTOMER USED THE FOOT PEDAL AND THE FUNCTION WAS NORMAL. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON WHICH INSTRUMENT WOULD NOT STOP MOVING. THE SURGEON'S HEAD WAS INSIDE THE HIGH RESOLUTION STEREO VIEWER ATTEMPTING TO MANIPULATE INSTRUMENTS WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372558 ↗
• MalfunctionSep 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295621 ↗
• MalfunctionSep 16, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD A 23025 ERROR. THE CUSTOMER STATED THAT THE LEFT MASTER TOOL MANIPULATOR (MTML) SUDDENLY BECAME UNUSABLE. THE CUSTOMER HAD ALREADY POWER CYCLED THE SYSTEM, AND THE ERROR RETURNED. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE SURGEON TO EXERCISE THE MTML IN EVERY ANGLE WHILE THE SYSTEM WAS OFF. THE TSE WARNED THE SURGEON THAT THE MTML FAULT COULD RETURN AT ANY TIME WITHOUT PREVENTION AND THAT THE MTML HAD TO BE REPLACED. THE ERROR RETURNED AFTER A NEW RESTART AND NO OTHER SURGEON SIDE CONSOLE (SSC) WAS AVAILABLE AT THE HOSPITAL SITE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON CONFIRMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE COULD BE CONTINUED LAPAROSCOPICALLY WITH THE ROBOT. THERE WAS NO PROBLEM FOR THE PATIENT APART FROM A SECONDARY ANEMIA ON AN UNCOLLECTED PARIETAL HEMATOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231229 ↗
• MalfunctionSep 10, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY (RADICAL SALVAGE) SURGICAL PROCEDURE, THE NURSE CONTACTED DVSTAT TO REPORT AN ISSUE. THE CALLER STATED THAT THE SYSTEM REPORTED ERROR CODE 857. THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE SITE TO HARD POWER CYCLE THE SYSTEM TWICE AND TO PRESS THE ERGONOMIC SWITCH SEVERAL TIMES BUT THE ISSUE REMAINED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI OBTAINED THE FOLLOWING INFORMATION BASED ON A FOLLOW-UP: THE PATIENT TOLERATED THE CHANGE WHEN THE PROCEDURE WAS CONVERTED. THE SYSTEM WAS INSPECTED PRIOR TO USE. NO ISSUES WERE NOTED DURING THE SET UP OF THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186786 ↗
• MalfunctionAug 27, 2024Material Integrity Problem; Material Integrity Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074268 ↗
• MalfunctionJun 24, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ERROR 25553 OCCURRED ON THE RIGHT MASTER TOOL MANIPULATOR (MTMR) MULTIPLE TIMES. THE TECHNICAL SERVICE ENGINEER (TSE) GUIDED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM. THE CUSTOMER STATED THAT THE ERROR REAPPEARED A FEW MINUTES AFTER POWER CYCLING THE SYSTEM. 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 PROCEDURE WAS COMPLETED USING THE ORIGINAL DA VINCI SYSTEM. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602119 ↗
• InjuryMar 14, 2024No Display/Image; No Display/Image

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908372 ↗