daVinci Xi 380799Recalls & reported problems
Intuitive Surgical, Inc. · PATIENT SIDE CART, RECERTIFIED · Class 2
All models of daVinci Xi (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874115497), received between Nov 11, 2024 and Sep 22, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (1 report).
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
- Failure to Sense1
- Visual Prompts will not Clear1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Failure to Sense
Patient problems: Insufficient Information
MAUDE report 50861274 ↗MalfunctionNov 11, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA ETEP SURGICAL PROCEDURE, A RECOVERABLE FAULT CONTINUED TO OCCUR ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SYSTEM WAS HARD POWER CYCLED, BUT THE ERROR REMAINED. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE BY DISABLING USM 4. TSE REMAINED ONLINE WHILE THE SURGEON DOCKED AND STARTED PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE AND THUS, PORTS WERE ALREADY PLACED WHEN THE USM 4 WAS DISABLED; THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH ONLY 3 USMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652903 ↗
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- daVinci Xi 380652Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls235 deaths5,316 reports
- daVinci Xi 381121Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall2 deaths4,310 reports
- EndoWrist 471405Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death3,770 reports
- EndoWrist 470327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,273 reports
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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