daVinci Xi 380652Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,316 adverse event reports that list this exact device (DI 00886874110720), received between Feb 11, 2019 and Sep 30, 2026 — classified as 235 deaths, 854 injuries, 4,227 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (2,198 reports).

2 FDA recall records name this device's identifier, 2 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. Jan 24, 2023Open, Classified

   Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

   Z-1262-2023 · Root cause: Component change control · Recall details · FDA record ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,316 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955020 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50953996 ↗
• MalfunctionSep 30, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953889 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953880 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50953744 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953500 ↗
• MalfunctionSep 30, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952349 ↗
• MalfunctionSep 30, 2026Output Problem

  It was reported that prior to starting a da Vinci-assisted surgical procedure, the customer encountered an error 32056 on the Universal Surgical Manipulator 4 (USM4). The Technical Service Engineer (TSE) had the customer emergency power off the Patient Side Cart but the error remained. The TSE advised the customer to disable the USM4, the customer stated that they would confirm with the surgeon that the case could be completed with three Universal Surgical Manipulator (USM)s. The procedure was completed with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50942442 ↗
• MalfunctionSep 30, 2026No Device Output; Visual Prompts will not Clear

  It was reported that the Universal Surgical Manipulator (USM) 1 had a non-recoverable fault 32056 when the system powered on. The customer power cycled the system five times, but the issue remained. The Intuitive Surgical, Inc. (ISI) Technical Service Engineer had the customer hard power cycle the system, but the error returned again. There was no report of patient involvement.ISI contacted the Clinical Territory Associate and obtained the following information: The issue was identified when setting up the Operating Room (OR) in the evening on the 6th to get the system ready for the next day. The two patients (procedures) were cancelled and are being rescheduled. No procedure was going on at the time of the event. The robot was isolated until a Field Service Engineer (FSE) was able to go on site. There was no delay involved, just cancellation of upcoming procedures. There was no injury to any patient. The FSE resolved the issue on the afternoon of the 7th.ISI contacted the Technical Support Engineer and obtained the following information: With error 32056, the customer could have used the system and proceeded with the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50942438 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, the user informed the Technical Support Engineer (TSE) that a repeated recoverable fault 32056 occurred on the Universal Surgical Manipulator (USM3). The user disabled USM3 and continued the procedure using the remaining three USMs without further issues. No known impact or patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942433 ↗
• MalfunctionSep 30, 2026Output Problem

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, the customer encountered an error 32056 on the Universal Surgical Manipulator (USM) 2. The customer power cycled the system several times, but the issue remained. The customer stated that they were moving the case to another room at the time of the call. The procedure was aborted to another da Vinci system with no patient involvement.

  Patient problems: Insufficient Information

  MAUDE report 50942422 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted procedure, following anesthesia and prior to port placement, the customer experienced recurrent recoverable errors 1105 and 1162 on Universal Surgical Manipulator (USM) arm#4. Upon reviewing the logs, the Intuitive Surgical Inc. (ISI) Technical Support Engineer (TSE) determined that USM#4 was faulty and required replacement. The TSE guided the caller to disable arm#4 and advised proceeding with the three remaining arms, which the customer indicated would most likely be sufficient for the upcoming procedure. However, the case was ultimately converted to open surgery. No patient injury was reported as a result of the issue or the conversion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942417 ↗
• MalfunctionSep 29, 2026No Device Output

  Patient problems: Insufficient Information

  MAUDE report 50939796 ↗
• MalfunctionSep 29, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50939338 ↗
• MalfunctionSep 29, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50939260 ↗
• MalfunctionSep 29, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937922 ↗
• MalfunctionSep 29, 2026Material Separation

  It was reported that outside of da Vinci-assisted surgical procedure, site contacted Intuitive Technical Support Engineer (TSE) to report crack in carriage of Universal Surgical Manipulator (USM) 2.There was no report of patient involvement.

  Patient problems: Insufficient Information

  MAUDE report 50928035 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  It was reported that during a da Vinci-assisted surgical procedure, the user informed the Technical Support Engineer (TSE) that repeated recoverable faults occurred on Universal Surgical Manipulator (USM) 3. The user disabled USM 3 and continued with the procedure using the remaining three USMs. The procedure was completed robotically as planned without delay and with no patient harm.On September 10, 2026, Intuitive Surgical (IS) obtained the following additional information regarding this event: Under a related complaint was opened to record the second procedure that took place on the afternoon of (b)(6) 2026, during which the customer experienced the same issue with the system.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928032 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted radical salvage prostatectomy surgical procedure, the site stated they were having recurring recoverable error 32056 on Universal Surgical Manipulators (USM) 1. The nurse restarted multiple times and error returned. The nurse was able to USM 1. The Technical Support Engineer (TSE) reviewed logs and informed that USM 1 was faulty and it has to be replaced. Upon request, the nurse was not able to state if the procedure could take place with the 3 remaining arms. The surgeon took over the call and did not answer to the question. TSE called back reporter to inform about the next step and to collect procedure information. The site informed that they would proceed with 3 Universal Surgical Manipulators (USM). The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928020 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted surgical procedure using an Xi system, user informed the Technical Support Engineer (TSE) that there was a continuous error on Universal Surgical Manipulator (USM) 2. Multiple hard power cycles of the Patient Side Cart (PSC) were performed, but the issue persisted. The TSE reviewed the system logs and confirmed the occurrence of the errors. The user converted the procedure to another dV system to continue with the procedure as planned. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50928019 ↗
• MalfunctionSep 29, 2026Material Split, Cut or Torn

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, user informed the Technical Support Engineer (TSE) that the Patient Side Cart power cable was damaged and the wall-plug end of the power cable had broken off. There was no report of patient involvement or patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50928015 ↗
• MalfunctionSep 29, 2026Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, the customer encountered a repeating error 32098 on the Universal Surgical Manipulator 3 (USM3). The customer was able to recover the error by adjusting the USM position but the error would return. The Technical Service Engineer advised the customer to perform a hard power cycle when possible.The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The customer did disabled the arm 3 and completed the case with the remaining three arms and a laparoscopic instrument in the arm 3 port. The issue cased a 30 minute surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928009 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted general inguinal hernia surgical procedure, a recoverable fault 32056 had been reported and error 32056 on Universal Surgical Manipulator (USM) arm 4 was observed. Technical Service Engineer (TSE) confirmed the error on the system logs. The customer performed an Emergency Power Off (EPO) of the Patient Side Cart (PSC); however, the issue persisted. The procedure was continuing with USM arm disabled with no report of patient involvement.

  Patient problems: Insufficient Information

  MAUDE report 50928007 ↗
• MalfunctionSep 29, 2026Output Problem

  It was reported that prior to start of da Vinci-assisted surgical procedure, site contacted Intuitive Technical Support Engineer (TSE) to report error 32056 on Universal Surgical Manipulator (USM) 3 and could not be cleared after restarting the system. I had the customer perform two hard power cycles, but the issue did not recover. Disabling the affected arm was difficult. The procedure was converted to laparoscopic with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50927998 ↗
• MalfunctionSep 28, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926065 ↗