daVinci Si 380990Recalls & reported problems

Summary

The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 00886874110874), received between Jun 2, 2020 and Sep 23, 2026 — classified as 20 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (71 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci-assisted surgical procedure, an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) was contacted after the operating room staff reported that the system displayed error 40006 and that a hard power cycle had not resolved the issue. The site had already engaged field support for troubleshooting prior to contacting the TSE, and the TSE documented the reported behavior and captured the error and contact identification information for follow-up. The procedure was converted to Laparoscopic Surgery with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The procedure was converted to traditional laparoscopic surgery. If converted to traditional laparoscopic, no additional ports were placed. The patient tolerated the change, and the surgery was completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864013 ↗
• MalfunctionSep 9, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702222 ↗
• MalfunctionJul 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092039 ↗
• MalfunctionMay 1, 2026Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 48245 OCCURRED. BEFORE CONTACTING THE TSE, THE CUSTOMER HAD POWER CYCLED THE SYSTEM AND REPLACED THE LAMP MODULE, BUT THE ISSUE PERSISTED. THE TSE ADVISED THE CUSTOMER TO USE THE THIRD-PARTY ILLUMINATOR TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONTINUED THE PROCEDURE WITH A THIRD-PARTY ILLUMINATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054177 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A BURNING SMELL WAS NOTED ON THE ILLUMINATOR. THERE WAS NO SYSTEM ERROR. THE CUSTOMER ELECTED TO USE A THIRD-PARTY ILLUMINATOR TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ILLUMINATOR AND THE BULB CONNECTING PLACE BURNT. THE CUSTOMER STATED THAT THE BURNING SMELL WAS HEAVY, AND THE ILLUMINATOR WAS NOT WORKING. REPLACING THE ILLUMINATOR WITH A THIRD-PARTY ILLUMINATOR WAS THE ONLY WAY TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25052478 ↗
• MalfunctionApr 26, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGICAL SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE ILLUMINATOR HAD NO LIGHT OUTPUT. NO ERROR WAS REPORTED, BEFORE CALLING TECHNICAL SUPPORT, AND SITE HAD USED A THIRD ILLUMINATOR TO CONTINUE PROCEDURE. IT WAS NOTED THAT THE LIGHT MODULE USED 707 HOURS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993605 ↗
• MalfunctionApr 20, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ERROR 31020. THE ISSUE PERSISTED EVEN AFTER A POWER CYCLE AND PROCEDURE COULD NOT BE COMPLETED AS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 24932794 ↗
• MalfunctionApr 20, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LAMP COULD NOT IGNITE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER ADVISED THE CUSTOMER TO RESET THE LAMP, REBOOT THE SYSTEM, AND VENTILATE THE VISION SIDE CART (VSC). THE CUSTOMER UNDERSTOOD AND CONTINUED THE CASE. THE PROCEDURE OUTCOME IS UNKNOWN WITH NO REPORTED INJURY. ISI CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM STATUS WAS PARTIALLY NORMAL. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH ORIGINAL SYSTEM CONFIGURATION WITH A THIRD PARTY ILLUMINATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932789 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE ERROR 252 OCCURRED AFTER SYSTEM POWER ON, ISSUE REMAINS AFTER CUSTOMER POWER CYCLED THE SYSTEM, THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED A VIDEO WITH CUSTOMER, TSE FOUND THE DOUBLE CAMERA CONTROLLER (DOCO) LED WAS OFF. TSE CHECKED DOCO AND THE ILLUMINATOR BREAKER CIRCUIT, THERE WERE NO ISSUES. AFTER SWAPPING THE POWER CABLE OF DOCO AND ILLUMINATOR, ERROR PERSISTED. POP-UP ERROR LOG SHOWED ERROR 307 POINTING TO DOCO. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709301 ↗
• MalfunctionMar 25, 2026Visual Prompts will not Clear; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, SYSTEM ERROR FAULT 48245 OCCURRED. THE CUSTOMER POWERED CYCLED THE SYSTEM AND REPLACED THE LAMP MODULE, BUT THE ISSUE REMAINED. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CALLER WITH INSTALLING A THIRD ILLUMINATOR, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694507 ↗
• MalfunctionMar 25, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, WITH NO PORT PLACEMENT AND NO ANESTHESIA ADMINISTERED, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING ERROR 31020 OCCURRING. THE REPORTED COMPLAINT PERSISTED AFTER A POWER CYCLE WAS PERFORMED ON THE DA VINCI SYSTEM, THE SURGICAL PROCEDURE COULD NOT BE COMPLETED AS PLANNED. TSE NOTED THAT ERROR 31020 INDICATED A COUNTER LIMIT ISSUE. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691661 ↗
• MalfunctionMar 25, 2026Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE AND PRIOR TO PORTS PLACEMENT, ERROR 86 OCCURRED, AND ALL BATTERY INDICATORS WERE RED. SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). TSE HAD SITE CHECK THE POWER CABLE, WALL PLUG AND RESEAT THE PLUG, BUT THE ISSUE WAS NOT RESOLVED. SITE ELECTED TO ABORT THE DA VINCI PROCEDURE AND CONTINUE WITH LAPAROSCOPIC SURGERY. DA VINCI SYSTEM WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691618 ↗
• MalfunctionMar 20, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654805 ↗
• MalfunctionFeb 26, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452621 ↗
• MalfunctionFeb 24, 2026Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED A FAULT WITH THE CAMERA HEAD NOT LIGHTING UP, AND THE SYSTEM DISPLAYED ERROR 48265. THE TSE SUGGESTED USING A THIRD ILLUMINATOR TO CONTINUE THE PROCEDURE. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426203 ↗
• MalfunctionFeb 17, 2026Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED DA VINCI SURGERY TECHNICAL ASSISTANCE TEAM (DVSTAT) AND REPORTED THAT ERROR 48245 OCCURRED AFTER THE CUSTOMER TRIED TO TURN ON THE LAMP MODULE. DUE TO THE LAMP NOT BEING ABLE TO BE IGNITED, THE CUSTOMER DECIDED TO USE A THIRD-PARTY ILLUMINATOR TO COMPLETE THE PROCEDURE. THE CUSTOMER COULD NOT HELP WITH CHECKING THE LAMP HOUR OR OTHER TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24371632 ↗
• MalfunctionJan 14, 2026Optical Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064731 ↗
• MalfunctionJan 7, 2026Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987078 ↗
• MalfunctionSep 19, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, A NURSE CONTACTED TECHNICAL SUPPORT TO REPORT THAT ERROR 25326 OCCURRED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO CHECK AND POWER CYCLE THE SYSTEM, BUT THE ISSUE PERSISTED. SUBSEQUENTLY, THE TSE SUGGESTED TO SWAP THE PATIENT SIDE CART (PSC) POWER SOCKET, BUT THE PROBLEM CONTINUED. DUE TO THESE UNRESOLVED ISSUES, THE PROCEDURE COULD NOT BE COMPLETED AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER ELECTED TO CONVERT TO TRADITIONAL LAPAROSCOPIC SURGERY AFTER THE DA VINCI SYSTEM WENT DOWN. THERE WERE NO INCREASES IN PORT INCISIONS, NOR WERE ADDITIONAL PORTS PLACED. THE PATIENT TOLERATED THE CONVERSION WELL, AND THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092916 ↗
• MalfunctionSep 16, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE LAMP FAILED TO IGNITE. INITIALLY, A REBOOT OF THE SYSTEM WAS ATTEMPTED, WHICH RESULTED IN THE LAMP TURNING ON; HOWEVER, THE INTENSITY WAS FOUND TO BE INSUFFICIENT. THE USER CONVERTED TO A LAPAROSCOPIC APPROACH TO CONTINUE WITH THE PROCEDURE. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT NO ADDITIONAL PORT INCISIONS WERE MADE, OR ADDITIONAL PORTS PLACED WHEN THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY. ADDITIONALLY, IT WAS STATED THAT THE PATIENT TOLERATED THE CHANGE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068783 ↗
• MalfunctionSep 10, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ILLUMINATOR WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021748 ↗
• MalfunctionSep 10, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT IMAGE DIDN'T SHOW AND SYSTEM POWERED OFF. TSE RECOMMENDED CALLER CHECKED POWER CORD AND GUIDED CALLER OPENED REAR DOOR OF VSC. CALLER STATED THE REAR OF VSC WAS TOO HOT. TSE RECOMMENDED CALLER LET VSC HAD GOOD VENTILATION. SYSTEM COULD POWER ON AUTOMATICALLY. PROCEDURE COULD COMPLETE AS PLANNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP BUT WAS ABLE TO ATTAIN MORE ADDITIONAL INFORMATION. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING THE SYSTEM. SYSTEM INITIALLY POWERED ON WITH NO ERRORS. ILLUMINATOR DID WORK IN THE PROCEDURE. PROCEDURE WAS COMPLETED IN THE ORIGINAL CONFIGURATION WITH THE SAME ILLUMINATOR. THE FIELD ENGINEER REPLACED THE ILLUMINATOR. PLEASE REFER TO SECTION A FOR PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012765 ↗
• MalfunctionSep 6, 2025No Display/Image; No Display/Image

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987293 ↗
• MalfunctionSep 2, 2025Optical Distortion; Optical Distortion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931341 ↗
• MalfunctionAug 27, 2025Failure to Calibrate; Failure to Calibrate

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901580 ↗