da Vinci Surgical SystemRecalls & reported problems across all models

We found 9 models of da Vinci Surgical System by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,459 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2020 and Sep 30, 2026 — classified as 13 deaths, 336 injuries, 1,109 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (235 reports).

5 FDA recall records name at least one of these models by its device identifier, 3 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. 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

da Vinci Surgical System 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. Apr 22, 2026Open, Classified

   Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

   Z-2521-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 13, 2024Open, Classified

   Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

   Z-1518-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. 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 · names 2 of these models · Recall details · FDA record ↗

4. Jun 22, 2022Completed

   Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

   Z-1484-2022 · Root cause: Process design · Recall details · FDA record ↗

5. Mar 3, 2022Completed

   Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

   Z-1210-2022 · Root cause: Use error · Recall details · FDA record ↗

Most reported da Vinci Surgical System problems

da Vinci Surgical System models

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

• da Vinci Energy 480440

  System, surgical, computer controlled instrument
  1 recall2 deaths493 reports
• da Vinci SP 380601

  System, surgical, computer controlled instrument
  2 recalls9 deaths286 reports
• da Vinci Xi 380721

  System, surgical, computer controlled instrument
  1 recall299 reports
• da Vinci Xi 380723

  System,surgical,computer controlled instrument
  1 recall170 reports
• da Vinci SP 380941

  System, surgical, computer controlled instrument
  133 reports
• da Vinci SP 380940

  System, surgical, computer controlled instrument
  1 death59 reports
• da Vinci Energy 378848

  System, surgical, computer controlled instrument
  1 recall3 reports
• da Vinci Energy 480522

  System, surgical, computer controlled instrument
  1 death15 reports
• da Vinci SP Endoscope, 0° 430600

  System, surgical, computer controlled instrument
  1 report

Recent da Vinci Surgical System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Power Up; Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50953697 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939505 ↗
• MalfunctionSep 29, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939481 ↗
• MalfunctionSep 29, 2026Energy Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, a remote site representative had contacted the Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) on behalf of the user site to report that monopolar energy could not be activated and that the cord indicator on the energy switch module had been amber while the other indicators had been blue. Prior to the call, users had verified that all cords had been connected correctly and had replaced the energy cord and the instrument, but the issue had persisted. The TSE had asked the caller to verify that the instrument cord had been connected to the energy switch module rather than the generator, and the caller had confirmed this had already been verified based on a photo of the setup. The TSE had then advised restarting the system, and the caller had planned to relay that instruction to the user site and call back; the call had ended before additional troubleshooting details had been obtained. The procedure outcome is unknown with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The case was completed robotically but the monopolar energy wasn't wor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928033 ↗
• MalfunctionSep 29, 2026Break; Failure to Seal

  It was reported that the sealing was not completed when using a Vessel Sealer Curved instrument. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50927510 ↗
• MalfunctionSep 29, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted surgical procedure, the Vessel Sealer Curved instrument jaws would not open. The procedure was completed. No known impact or patient consequence was reported.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: There was no injury to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927498 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted surgical procedure, the Vessel Sealer Curved instrument jaws would not open. The procedure was completed. No known impact or patient consequence was reported.ISI followed up with the initial reporter and obtained the following additional information: There was no injury to the patient. The instrument was returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924010 ↗
• MalfunctionSep 26, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906735 ↗
• MalfunctionSep 25, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905863 ↗
• MalfunctionSep 25, 2026Material Fragmentation; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905857 ↗
• MalfunctionSep 25, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50905524 ↗
• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: Insufficient Information

  MAUDE report 50904522 ↗
• 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, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891143 ↗
• MalfunctionSep 24, 2026No Device Output; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890908 ↗

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
• Ion6 models · 1,367 reports · 3 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall
• daVinci Si8 models · 681 reports · 1 recall