daVinci SiRecalls & reported problems across all models

We found 8 models of daVinci Si by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 681 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Sep 30, 2026 — classified as 13 deaths, 91 injuries, 577 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (210 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

daVinci Si recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

Most reported daVinci Si problems

daVinci Si models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• daVinci Si 380614

  System,surgical,computer controlled instrument
  1 recall12 deaths271 reports
• daVinci Si 380990

  System,surgical,computer controlled instrument
  190 reports
• daVinci Si 380610

  System,surgical,computer controlled instrument
  1 recall130 reports
• daVinci Si 380649

  System,surgical,computer controlled instrument
  1 recall0 reports
• daVinci Si 380686

  System,surgical,computer controlled instrument
  1 death29 reports
• daVinci Si 380690

  System,surgical,computer controlled instrument
  23 reports
• daVinci Si 380675

  System,surgical,computer controlled instrument
  21 reports
• daVinci Si 380689

  System,surgical,computer controlled instrument
  17 reports

Recent daVinci Si adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 22, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861010 ↗
• MalfunctionSep 9, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702222 ↗
• MalfunctionAug 26, 2026Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, the customer called a Field Service Engineer (FSE) and reported that the system had an error 25596 on the Armnet1 Remote Arm Controller 1 (RAC1). The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: Error could not be resolved, arm1 disabled, they continued and completed the procedure with two remaining arms, in the original configuration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50445764 ↗
• MalfunctionAug 11, 2026Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, the customer called an ISI Technical Support Engineer (TSE) and reported a non-recoverable error 22023 on the Patient Side Manipulator (PSM). The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: Error was not resolved; the site continued and completed the procedure with two arms. The system was still in the original configuration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215063 ↗
• MalfunctionJul 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092039 ↗
• DeathJul 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PARTIAL NEPHRECTOMY FOR TUMOR REMOVAL, THE PATIENT¿S RENAL ARTERY WAS DAMAGED; ALTHOUGH THE ARTERY WAS REPAIRED, POST-OPERATIVE BLEEDING OCCURRED AND THE PATIENT EXPIRED. THE SOURCE OF THE INFORMATION WAS FROM UNSPECIFIED MEDIA COVERAGE OF THE EVENT. THE UNCONFIRMED SOURCE DATA REPORTED THAT THE BLEEDING VESSEL WAS SUTURED, BUT THE SUTURE THREAD BROKE, RESULTING IN FEWER LIGATIONS (2-3 TIMES) THAN NORMAL. ADDITIONAL SUTURES WERE PERFORMED AFTER THE BREAKAGE, BUT THE HEMOSTASIS WAS STILL INSUFFICIENT WHICH LED TO POST-OPERATIVE BLEEDING. THE PATIENT¿S POST-OPERATIVE CONDITION WORSENED. THE PATIENT RECEIVED ADDITIONAL INTERVENTIONS, INCLUDING KIDNEY REMOVAL AND BLOOD TRANSFUSIONS. THE PATIENT EXPIRED FROM HEMORRHAGIC SHOCK ON POST-OPERATIVE DAY ONE. THE SOURCE OF THE INFORMATION WAS FROM UNSPECIFIED MEDIA COVERAGE OF THE EVENT. THE HOSPITAL REPORTS THAT THEY INVESTIGATED THE EVENT AND CONCLUDED THE CAUSE OF DEATH WAS RE-BLEEDING AS A RESULT OF LOOSENING OF THE SUTURES AT THE HEMOSTASIS SITE. THE HOSPITAL PLANS TO IMPLEMENT A SYSTEM WHERE MULTIPLE PHYSICIANS CONFIRM HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25713093 ↗
• MalfunctionMay 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING THE HARMONIC ACE BEING UNABLE TO ROTATE. TSE GUIDED THE CUSTOMER TO RESEAT THE HARMONIC ACE AND THE STERILE ADAPTER. THE CUSTOMER NOTED THAT THE REPORTED COMPLAINT REMAINED. TSE INSTRUCTED THE CUSTOMER TO POWER CYCLE THE DA VINCI SYSTEM WHEN IT WAS CONVENIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212260 ↗
• MalfunctionMay 11, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 31020 WAS TRIGGERED. A POWER CYCLE WITH EMERGENCY POWER OFF (EPO) DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25143696 ↗
• 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 ↗
• 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 29, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN SI SYSTEM, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 17 APPEARED WHEN THE SYSTEM WAS POWERED ON. THE SITE REBOOTED THE SYSTEM, BUT THE ISSUE PERSISTED. THE USER PROVIDED ERROR DETAILS, AND TSE IDENTIFIED ADDITIONAL ERRORS THAT INDICATED A PROBLEM ASSOCIATED WITH THE PATIENT SIDE CART (PSE), LEADING TO GUIDANCE TO RESET THE POWER CABLE AND THE BLUE FIBER CABLE FOR THAT COMPONENT. AFTER THESE STEPS WERE FOLLOWED AND THE SYSTEM WAS REBOOTED, A NEW ERROR 802 APPEARED, AND TSE THEN ADVISED CHECKING THE EMERGENCY POWER-OFF CIRCUIT, BUT THIS DID NOT RESTORE NORMAL OPERATION. THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC APPROACH. 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 25036991 ↗
• 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 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 recalls
• daVinci Xi4 models · 11,477 reports · 3 recalls
• EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
• daVinci 53 models · 1,608 reports · 5 recalls
• da Vinci Surgical System9 models · 1,459 reports · 5 recalls
• Ion6 models · 1,367 reports · 3 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall