daVinci Xi 381121Recalls & reported problems
Intuitive Surgical, Inc. · VISION SIDE SYSTEM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This da Vinci Xi vision side system is part of Intuitive's robotic surgical system. Its 4,368 adverse event reports mostly describe energy output problems and generator error codes, and some describe burns and bleeding. The reports include 2 deaths and 264 injuries. 1 recall names this device: started in September 2022 and still open, it covers energy being delivered unintentionally when certain bipolar instruments and generator connections are combined.
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
- 4,310
- Deaths reported
- 2
- Injuries reported
- 266
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,310 adverse event reports that list this exact device (DI 00886874110898), received between Dec 15, 2016 and Sep 30, 2026 — classified as 2 deaths, 266 injuries, 4,040 malfunctions.
The most frequently reported specific device problem is “Output Problem” (1,925 reports).
1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Output Problem1,925
- Visual Prompts will not Clear900
- Energy Output Problem582
- Failure to Deliver Energy297
- Grounding Malfunction147
- Power Problem112
- No Device Output75
- Continuous Firing59
Patient problems
- No Clinical Signs, Symptoms or Conditions3,796
- Insufficient Information309
- Unspecified Tissue Injury106
- Hemorrhage/Blood Loss/Bleeding41
- Burn(s)38
- No Known Impact Or Consequence To Patient17
- Bowel Perforation4
- Full thickness (Third Degree) Burn3
Recent adverse event reports
The 25 most recent of 4,310 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954542 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954384 ↗MalfunctionSep 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953600 ↗MalfunctionSep 30, 2026Output Problem
It was reported that prior to start of da Vinci-assisted benign hysterectomy surgical procedure, site contacted Intuitive Technical Support Engineer (TSE) to report Integrated ElectroSurgical Unit (IESU) powered off during preparation of procedure. The customer turned on IESU. There was activation sound continuously. TSE reviewed event logs via onsite. M 19, M 36 were recorded. The procedure was continued with force triad. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942421 ↗MalfunctionSep 30, 2026Output Problem
It was reported that Universal Surgical Manipulator (USM) 2 faulted with error 32056 while the site's Clinical Sales Representative (CSR) was troubleshooting video issues. The Intuitive Surgical Inc Technical Support Engineer (TSE) reviewed the system logs and confirmed the reported error. The TSE had the CSR perform a hard reboot, with no change. The caller stated that the site has several cases scheduled for the following day that they would need all 4 USMs for. There were no reports of patient involvement.
Patient problems: Insufficient Information
MAUDE report 50942414 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939848 ↗MalfunctionSep 29, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939638 ↗MalfunctionSep 29, 2026Output Problem
It was reported that prior to starting a da Vinci-assisted surgical procedure, an error occurred during startup and did not clear after a restart. The troubleshooting first confirmed the initial code as a different error code, and it was noted that an extension cable had been in use. The connection was then changed and the unit was restarted, but the error still did not clear. An alternate device was available onsite but had not been integrated, so the integration method was explained and an external pedal option was discussed, though those options were not accepted. After the error, integrated mode had been used and ¿Not Available¿ had displayed during use, making energy activation unavailable. The installed instruments across all arms were reviewed, and it was considered whether one instrument might have been detected as a second bipolar instrument. Instructions were provided to discontinue integrated operation and set up the external pedal, after which energy output had been available via the pedal even though ¿Not Available¿ continued to display. The customer was to test further and recontact support if energy output remained unavailable.The procedure was completing as planned
Patient problems: Insufficient Information
MAUDE report 50928040 ↗MalfunctionSep 29, 2026Output Problem
It was reported that during a da Vinci-assisted Pulmonary Lobectom surgical procedure, user informed the Technical Support Engineer (TSE) that ERBE error C-34 occurred repeatedly. The user stated the ERBE generator had already been restarted, but the issue persisted. The user continued with the procedure using the FT10 generator without further issues. No known impact or patient consequence was reported.Intuitive followed up but no additional information was available. No patient information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928034 ↗MalfunctionSep 29, 2026Output Problem
It was reported that during a training/demo of the da Vinci system, the external bipolar pedal had been sticking and had caused a system error. Technical Service Engineer (TSE) guided the caller to disconnect the pedal from the energy device, which cleared the error. There was no report of patient involvement.
Patient problems: Insufficient Information
MAUDE report 50928005 ↗MalfunctionSep 28, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926057 ↗MalfunctionSep 28, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50925981 ↗MalfunctionSep 28, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50924917 ↗InjurySep 28, 2026Visual Prompts will not Clear
Patient problems: Unspecified Tissue Injury
MAUDE report 50918155 ↗InjurySep 28, 2026Energy Output Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50915536 ↗MalfunctionSep 27, 2026Power Problem
Patient problems: Insufficient Information
MAUDE report 50909579 ↗MalfunctionSep 27, 2026Visual Prompts will not Clear; Output Problem
Patient problems: Insufficient Information
MAUDE report 50909578 ↗MalfunctionSep 25, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905258 ↗MalfunctionSep 25, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905031 ↗MalfunctionSep 25, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50904524 ↗MalfunctionSep 25, 2026Visual Prompts will not Clear
It was reported that during a da Vinci-assisted surgical procedure that non recoverable fault 86 occurred. The customer hard power cycled the system and performed an emergency power off, but the error reoccurred. The customer converted the procedure to laparoscopic. There were no reports of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900751 ↗MalfunctionSep 25, 2026Output Problem
It was reported that during da Vinci-assisted surgical procedure, ERBE had C00 error. No further information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893632 ↗MalfunctionSep 24, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50891432 ↗MalfunctionSep 24, 2026Continuous Firing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890920 ↗MalfunctionSep 24, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50890919 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.