daVinci 5 380747Recalls & reported problems
Intuitive Surgical, Inc. · Patient Side Cart · Class 2
All models of daVinci 5 (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This da Vinci 5 surgical robot is a computer-controlled system used in surgery. Many of the 580 reports describe on-screen error messages that will not clear, and some mention arms overheating or moving unexpectedly. The reports include 12 deaths and 70 injuries, and reports rose from 113 in the previous 12 months to 457 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 572
- Deaths reported
- 14
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 572 adverse event reports that list this exact device (DI 00886874119716), received between Apr 30, 2024 and Sep 30, 2026 — classified as 14 deaths, 70 injuries, 488 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (269 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.
Reports received per month
Most reported problems
Device problems
- Visual Prompts will not Clear269
- Output Problem88
- Adverse Event Without Identified Device or Use Problem55
- No Device Output27
- Positioning Problem25
- Unintended Movement23
- Unintended System Motion19
- Connection Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions452
- Insufficient Information50
- Hemorrhage/Blood Loss/Bleeding28
- Unspecified Tissue Injury25
- Cardiac Arrest6
- Hematoma3
- Bowel Perforation2
- Fever2
Recent adverse event reports
The 25 most recent of 572 reports, in the reporter's own words as published by the FDA.
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 28, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925842 ↗MalfunctionSep 28, 2026Visual Prompts will not Clear
Patient problems: Insufficient Information
MAUDE report 50925830 ↗MalfunctionSep 26, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906720 ↗MalfunctionSep 25, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905861 ↗InjurySep 25, 2026Visual Prompts will not Clear
Patient problems: Unspecified Tissue Injury
MAUDE report 50902775 ↗MalfunctionSep 23, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875854 ↗MalfunctionSep 22, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861939 ↗MalfunctionSep 22, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860983 ↗MalfunctionSep 22, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860749 ↗MalfunctionSep 22, 2026Unintended Movement
It was reported that during a da Vinci-assisted cholecystectomy surgical procedure, Intuitive Surgical, Inc. (ISI) Clinical Sales Representative (CSR) informed Technical Support Engineer (TSE) that when the surgeon was using head in menu to change from 30 up to 30 down, the horizon was inverted. The surgeon had to manually move the orientation to resolve the issue. The endoscope was installed on Universal Surgical Manipulator (USM) 2. The customer continued to use USM 2 for the procedure. The procedure was completing as planned with no reported injury. On the following day, the CSR called in to provide more information about the issue. The TSE was informed that the issue had not recurred during the subsequent case. The TSE walked the CSR through checking the presence pins on the Universal Surgical Manipulator (USM) and the disc integrity, with the CSR verifying that all felt solid and that no oddities were found. The TSE then had the CSR compare the carriage integrity of the USM to another USM, and the CSR confirmed that no irregularities were found. The TSE advised the CSR that if the issue were to occur again on the USM, port hopping could be utilized as an option.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852640 ↗MalfunctionSep 11, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744281 ↗MalfunctionSep 10, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724245 ↗MalfunctionSep 10, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723868 ↗DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50673579 ↗MalfunctionSep 5, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50626903 ↗MalfunctionSep 4, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618939 ↗MalfunctionSep 4, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618938 ↗MalfunctionSep 4, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618936 ↗MalfunctionSep 1, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553081 ↗MalfunctionAug 27, 2026Visual Prompts will not Clear
It was reported that during a da Vinci-assisted surgical procedure, the customer reported that the arm temperature was higher than normal. The caller reported the system had been on since about 6 am that morning and draped for the last 30 to 45 minutes. The Technical Support Engineer (TSE) advised the caller to reposition the system arms to allow for adequate air flow. The TSE viewed the logs and noted an error 1119 in the logs pointing to an AC fan error. The customer continued with the case. The customer called back about the Universal Surgical Manipulator (USM) overheating. The caller said the site put a gown over the system arms after draping and waiting for the case to start. The TSE informed that third party covers like a gown can act like a blanket not allowing the USM to properly cool. They were going to disable USM 1 and do the case as a 3 arm system and power cycle between cases. The procedure was continued as planned with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The procedure was continued with three system arms instead of four. The customer was unable to resolve the error m
Patient problems: Insufficient Information
MAUDE report 50468051 ↗
Other System, surgical, computer controlled instrument devices
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- EndoWrist 471405Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death3,770 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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