daVinci 5 380730Recalls & reported problems

Summary

The FDA's MAUDE database contains 579 adverse event reports that list this exact device (DI 00886874119747), received between May 2, 2024 and Sep 30, 2026 — classified as 20 injuries, 557 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (369 reports).

4 FDA recall records name this device's identifier, 4 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, 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. 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   Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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 ↗

2. 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 ↗

3. 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 ↗

4. 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 problems

Recent adverse event reports

The 25 most recent of 579 reports, 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 ↗
• 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: Insufficient Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925881 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925547 ↗
• MalfunctionSep 28, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924604 ↗
• MalfunctionSep 28, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923411 ↗
• MalfunctionSep 28, 2026Output Problem

  Refer to H11 for Follow-Up information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910836 ↗
• MalfunctionSep 28, 2026Positioning Problem

  It was reported that during a da Vinci assisted surgical procedure, the customer contacted the Technical Support Engineer (TSE) and reported that the instrument installed in Universal Surgical Manipulator (USM)1 would not open without manual assistance from another instrument. A system restart was attempted by the staff, during which a boom disabled message was displayed. Error 31089 was identified, pointing to the upper right blue fiber port. It was recommended that the fiber cable from the Patient Side Cart (PSC) be swapped to a new port. The cable was swapped and the system was restarted, powering up normally however, the instrument in Universal Surgical Manipulator (USM)1 still could not be opened. It was then recommended that control be taken from the second Surgeon Side Console (SSC). Upon moving to the alternate console, the USM1 instrument was opened without issue, and the staff proceeded using USM2 as the active console. The procedure was completing as planned with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910832 ↗
• MalfunctionSep 26, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906726 ↗
• MalfunctionSep 25, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905755 ↗
• MalfunctionSep 22, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861248 ↗
• OtherSep 22, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci-assisted malignant hysterectomy procedure, the left hand Master Tool Manipulator (MTM), failed on the Surgeon Side Console (SSC), prompting the customer to contact an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) for assistance. Prior to reaching out, the surgeon had already removed the instruments from the patient and Universal Surgical Manipulators (USM), and performed a mid-procedure restart. However, the issue persisted. Upon engagement, the TSE confirmed error codes pointing to the left MTM based on a review of the logs and guided the customer through an additional power cycle, which included switching the SSC breaker to OFF. The blue fiber cable was verified to be seated correctly, and the customer turned the breaker back to ON. Although the system initialized successfully, the fault condition remained unchanged, with on-screen prompts offering options to either restart or disable the left manipulator. A further restart was attempted by the TSE, but the issue continued without resolution. The customer stated that, as an alternate da Vinci system was not available, the case was converted to an alternative surgical proced

  Patient problems: Insufficient Information

  MAUDE report 50855446 ↗
• MalfunctionSep 22, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci assisted surgical procedure, the customer contacted the Technical Support Engineer (TSE) and reported that the system was displaying a message instructing the user to shut down. The logs were reviewed and the issue was confirmed. Troubleshooting determined that the right arm on the console was causing the problem, as it was not recognized by the console. The procedure was converted to another DV system.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850343 ↗
• MalfunctionSep 16, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795447 ↗
• MalfunctionSep 10, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724542 ↗
• MalfunctionSep 10, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724501 ↗
• MalfunctionSep 4, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50618940 ↗
• MalfunctionSep 3, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598204 ↗
• MalfunctionSep 2, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576071 ↗
• MalfunctionAug 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491282 ↗
• MalfunctionAug 25, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441010 ↗