daVinci 5Recalls & reported problems across all models

We found 3 models of daVinci 5 by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,608 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2024 and Sep 30, 2026 — classified as 16 deaths, 130 injuries, 1,460 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (886 reports).

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

daVinci 5 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 24, 2026Open, Classified

   Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

   Z-2310-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 30, 2025Open, Classified

   Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

   Z-1355-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. Nov 17, 2025Open, Classified

   An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

   Z-1428-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

4. Feb 26, 2025Open, Classified

   Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

   Z-1325-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. Aug 21, 2024Open, Classified

   Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

   Z-0964-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported daVinci 5 problems

daVinci 5 models

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

• daVinci 5 380730

  System, surgical, computer controlled instrument
  4 recalls579 reports
• daVinci 5 380747

  System, surgical, computer controlled instrument
  14 deaths572 reports
• daVinci 5 380746

  System, surgical, computer controlled instrument
  1 recall2 deaths457 reports

Recent daVinci 5 adverse event reports

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

• MalfunctionSep 30, 2026Output Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954000 ↗
• DeathSep 30, 2026Insufficient Device Problem Information

  It was reported that following a da Vinci-assisted hiatal hernia procedure, the patient developed an incarcerated trocar-site hernia and subsequently expired. On postoperative day five, the patient presented to the emergency room, where the hernia was identified and an unspecified subsequent procedure was performed. The cause and date of death, as well as additional details regarding the events leading to the death, were not provided. Attempts to obtain additional information from the surgeon and site were unsuccessful.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50948206 ↗
• InjurySep 29, 2026Image Orientation Incorrect; Unintended Movement

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940901 ↗
• MalfunctionSep 29, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939695 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939643 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939641 ↗
• MalfunctionSep 29, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939474 ↗
• MalfunctionSep 29, 2026Vibration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939343 ↗
• MalfunctionSep 29, 2026No Device Output

  It was reported that during a training/demo of the da Vinci system, the Clinical Sales Representative (CSR) observed the right Master Tool Manipulator (MTM) was not working properly on the system. A work order was requested for demo/Not For Human Use (NFHU) system due to the right MTM malfunction. Logs were not available at the time of the report. Following a restart of the system, the right MTM remained unstable. It was also noted that ergonomics needed to be checked, though no further information was provided on that matter. There was no report of patient involvement or reported injury.Intuitive Surgical, Inc. (ISI) obtained the following additional information: On this console, none of the ergonomic adjustments were working. The armrest height, pedal depth, and viewer were completely non functional, and the message ¿Ergonomics Error¿ appeared on the display. The console was restarted several times, and the ergonomics only started working after approximately the fifth restart. However, this did not last long, and the right MTM stopped working during a simulation exercise. The console was restarted several times. In this condition, the console is not suitable for demonstration pur

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927990 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926101 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926058 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926027 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926024 ↗
• MalfunctionSep 28, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50925987 ↗
• MalfunctionSep 28, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925881 ↗

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
• 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
• daVinci Si8 models · 681 reports · 1 recall