da Vinci XiRecalls & reported problems across all models

We found 2 models of da Vinci Xi by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 469 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2020 and Sep 29, 2026 — classified as 36 injuries, 433 malfunctions.

The most frequently reported specific device problem is “Output Problem” (128 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

da Vinci Xi recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported da Vinci Xi problems

da Vinci Xi models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• da Vinci Xi 380721

  System, surgical, computer controlled instrument
  1 recall299 reports
• da Vinci Xi 380723

  System,surgical,computer controlled instrument
  1 recall170 reports

Recent da Vinci Xi adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939481 ↗
• MalfunctionSep 26, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906735 ↗
• MalfunctionSep 25, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50905524 ↗
• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: Insufficient Information

  MAUDE report 50904522 ↗
• MalfunctionSep 25, 2026No Device Output

  It was reported that during a da Vinci-assisted surgical procedure, the customer reported that the bottom monopolar port on the Integrated ElectroSurgical Unit (IESU) was not functioning, displaying a question mark when instruments were attached. Different instruments and energy cords were tested but the port still failed to recognize them. The top monopolar port remained functional. The Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) log review showed no related errors. The procedure was completed, and no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893636 ↗
• MalfunctionSep 24, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891143 ↗
• MalfunctionSep 24, 2026Unexpected Shutdown

  It was reported that during a da Vinci-assisted retroperitoneal anterior partial nephrectomy surgical procedure, an Intuitive Surgical (IS) Technical Support Engineer (TSE) was contacted for by the customer to report that the system shuts down by itself, mid procedure. As System was not OnSite connected, no logs were available, TSE asked customer to take pictures on the event logs in the touchscreen of the Vision Side Cart (VSC), but nothing received yet. No idea what triggered the shut down or on which Surgeon Side Console (SSC). A Field Service Engineer (FSE) would need to go on site to upload the logs so they can be analyzed to see what are the recommended actions. System was hard power cycled due to other problems. The procedure was completed with no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877566 ↗
• MalfunctionAug 13, 2026Output Problem

  It was reported that the user observed errors M-02 and C-00 when powering on the generator. The user restarted the unit only, but the same issue persisted. There was no report of patient involvement or patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243418 ↗
• MalfunctionAug 13, 2026Failure to Power Up

  Patient problems: Insufficient Information

  MAUDE report 50236932 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear; Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50231339 ↗
• MalfunctionAug 13, 2026No Display/Image

  Patient problems: Insufficient Information

  MAUDE report 50231290 ↗
• MalfunctionAug 12, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50229593 ↗
• InjuryAug 12, 2026Output Problem

  It was reported that during a da Vinci-assisted transvesical prostatectomy procedure, an error on the ERBE generator occurred during coagulation. Prior to calling an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE), the customer rebooted the ERBE generator, disconnected and reconnected the energy cables. The TSE inquired about the monopolar energy settings. The customer stated the monopolar energy was at level 3 with swift mode. The TSE asked what error codes were observed as the system was offline. The customer identified a possible error. The TSE asked the customer to switch to Classic mode, but the error persisted. The TSE advised the customer to shut down and unplug the ERBE generator, and wait 10 to 15 seconds before restarting the unit. After rebooting, two possibly related errors were observed. The TSE advised the customer to use a backup generator or another da Vinci system; however, the customer said there was no available backup. The customer elected to abort the procedure after ports had already been placed. The procedure was rescheduled and completed the next day. The patient is reported to be doing well.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50228451 ↗
• MalfunctionAug 12, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228051 ↗
• MalfunctionAug 11, 2026No Display/Image

  It was reported that prior to starting a da Vinci-assisted surgical procedure using a Xi system, an Operating Room (OR) staff called in to report that the Right High Resolution Stereo Viewer (HRSV-R) on the Surgeon Side Console (SSC) was black during case setup. The Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) walked the customer through a hard power cycle, but there was no change. As a result, the surgeon elected to abort to another dV system. Upon review, the TSE found error 121 on SSC 2, pointing to a suspect right eye HRSV monitor. No known impact or patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216606 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 recalls
• daVinci Xi4 models · 11,477 reports · 3 recalls
• EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
• daVinci 53 models · 1,608 reports · 5 recalls
• da Vinci Surgical System9 models · 1,459 reports · 5 recalls
• Ion6 models · 1,367 reports · 3 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall