daVinci Xi 380677Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,849 adverse event reports that list this exact device (DI 00886874110744), received between Feb 14, 2020 and Sep 30, 2026 — classified as 2 deaths, 107 injuries, 1,740 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (565 reports).

2 FDA recall records 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

2. Jul 16, 2018Terminated

   Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

   Z-3254-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,849 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Optical Discoloration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953887 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50953593 ↗
• MalfunctionSep 30, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted surgical procedure, the arms on the Surgeon Side Console (SSC) moved or drifted when the Surgeon logged on. The customer was unsure if the arms on the Patient Side Cart (PSC) moved. The customer was concerned there was something wrong and power cycled the system prior to calling into Technical Support. The Technical Service Engineer (TSE) noted the logs were not available. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951931 ↗
• MalfunctionSep 30, 2026No Display/Image

  It was reported that during a demo of the da Vinci system, the right eye was black. There was no report of patient involvement or reported injury.Intuitive Surgical, Inc. (ISI) followed up with the Field Service Engineer (FSE) and obtained the following additional information: The demo was successfully completed with the system in its current condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942436 ↗
• MalfunctionSep 25, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905860 ↗
• MalfunctionSep 25, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904648 ↗
• MalfunctionSep 25, 2026Unintended System Motion

  It was reported that during da Vinci-assisted surgical procedure, site contacted Intuitive Technical Support Engineer (TSE) to report a fault. Caller stated that USM#1 was out of control. After power cycle system, issue disappeared and the procedure was completing as planned. System did not show any errors. The procedure was completed with no reported injury.Intuitive followed up and obtained additional information. USM did not move with unintuitive motion. Surgeon found that MTML GRIP could not control the instrument on the USM 1. The issue did occur with the surgeon¿s head inside the Surgeon Console¿s High Resolution Stereo Viewer. The issue did occur while the surgeon was attempting to manipulate instruments from the Surgeon Console. The movements of the surgeon scale appropriately to the Universal Surgical Manipulator (USM). The USM did not move in the intended direction (intended direction right and observed instrument movement right). The timing of the USM movement was appropriate. There was no shakiness. There was no system arm-to-arm interference. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900298 ↗
• MalfunctionSep 24, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891426 ↗
• MalfunctionSep 24, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890595 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875981 ↗
• InjurySep 23, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci-assisted thoracic procedure, after port placement, the system encountered with multiple system errors in the middle of the surgical procedure. The error messages were indicating towards cleaning of the fiber cables. The customer informed that the procedure was already converted to open surgery by the surgeon prior connecting with the Technical Support Engineer (TSE) and reseated the fiber cables when the system was ON, but the issue persisted. TSE reviewed logs and confirmed the communication error with the Surgeon Side Console (SSC). TSE guided the customer to clean the fiber cables and make a hard power cycle with Emergency Power Off (EPO) button. The customer stated they will do it after the surgery.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50867965 ↗
• MalfunctionSep 1, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543247 ↗
• MalfunctionAug 28, 2026Unintended System Motion

  Patient problems: Insufficient Information

  MAUDE report 50509723 ↗
• MalfunctionAug 25, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50440378 ↗
• MalfunctionAug 25, 2026Unintended System Motion; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439669 ↗
• MalfunctionAug 22, 2026Positioning Problem

  Patient problems: Insufficient Information

  MAUDE report 50385110 ↗
• MalfunctionAug 17, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288073 ↗
• MalfunctionAug 13, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231335 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50231269 ↗
• MalfunctionAug 12, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229354 ↗
• MalfunctionAug 11, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216667 ↗
• MalfunctionAug 11, 2026Visual Prompts will not Clear

  It was reported that prior to starting a da Vinci-assisted surgical procedure using an Xi system, and after surgical port placement, an Intuitive Surgical, Inc. (ISI) Field Service Engineer (FSE) called from offsite to report error 903 occurred. The Technical Support Engineer (TSE) reviewed the logs and found error 25514 for Remote Arm Controller (RAC) 2. The site performed a couple of power cycles, but the error persisted. The procedure was converted to another dV system, and no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215568 ↗
• MalfunctionAug 11, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci-assisted surgical procedure, non-recuperable error occurred on the second Surgeon Side Console (SSC). Logs show error 23008 was pointing to left Master Tool Manipulator (MTM). The procedure was completing as planned with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: Field Service Engineer (FSE) confirmed issue was related to Surgeon Side Console (SSC) 2 and it was disconnected. The procedure was completed using only SSC 1. The issue was not resolved over the phone, and the customer came to the conclusion to disable SSC 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203281 ↗
• MalfunctionAug 10, 2026Visual Prompts will not Clear

  It was reported that prior to start- pre anesthesia in a da Vinci-assisted surgical procedure, no ports placed, the customer identified multiple non- recoverable error messages/ faults on the system while starting the system. The customer rebooted the system using a hard power cycle and swapped and cleaned the Blue Fiber Cable (BFC) but issue did not resolved. The customer decided to proceed laparoscopically without contacting the Technical Support Engineer (TSE). TSE contacted customer after the procedure was completed and asked to perform another power cycle, but the issue persisted. TSE checked system logs and confirmed error message/ fault pointing towards Personality Module Surgeon Console (PMSC) of the Surgeon Side Console (SSC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189556 ↗
• MalfunctionAug 8, 2026Output Problem

  It was reported that during an internal service activity, the Surgeon encounter a recoverable fault ERROR 25520 on the Master Tool Manipulator (MTM-R). There was no reported patient involvement. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The fault happened when turning on the system. The customer helped to turn on the system to check on the OnSite of the system. The customer said it encounter recover fault. The issue did not happen during Preventative Maintenance (PM).

  Patient problems: Insufficient Information

  MAUDE report 50185185 ↗