da Vinci SPRecalls & reported problems across all models

We found 3 models of da Vinci SP by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 478 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2020 and Sep 30, 2026 — classified as 10 deaths, 170 injuries, 298 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (109 reports).

2 FDA recall records name at least one of these models by its device 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. 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 SP 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. Apr 22, 2026Open, Classified

   Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

   Z-2521-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 13, 2024Open, Classified

   Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

   Z-1518-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported da Vinci SP problems

da Vinci SP models

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

• da Vinci SP 380601

  System, surgical, computer controlled instrument
  2 recalls9 deaths286 reports
• da Vinci SP 380941

  System, surgical, computer controlled instrument
  133 reports
• da Vinci SP 380940

  System, surgical, computer controlled instrument
  1 death59 reports

Recent da Vinci SP adverse event reports

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

• MalfunctionSep 30, 2026Failure to Power Up; Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50953697 ↗
• MalfunctionSep 29, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939505 ↗
• MalfunctionSep 29, 2026Energy Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, a remote site representative had contacted the Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) on behalf of the user site to report that monopolar energy could not be activated and that the cord indicator on the energy switch module had been amber while the other indicators had been blue. Prior to the call, users had verified that all cords had been connected correctly and had replaced the energy cord and the instrument, but the issue had persisted. The TSE had asked the caller to verify that the instrument cord had been connected to the energy switch module rather than the generator, and the caller had confirmed this had already been verified based on a photo of the setup. The TSE had then advised restarting the system, and the caller had planned to relay that instruction to the user site and call back; the call had ended before additional troubleshooting details had been obtained. The procedure outcome is unknown with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The case was completed robotically but the monopolar energy wasn't wor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928033 ↗
• MalfunctionSep 25, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905863 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890607 ↗
• MalfunctionSep 24, 2026Output Problem

  It was reported that during a da Vinci assisted ureteroplasty surgical procedure, the sheath indicator on the Energy Shield Monitor (ESM) displayed yellow with a warning related to the instrument sheath/cord. The procedure was completed as planned with no patient injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The customer noted the procedure was continued and completed despite the yellow cord/sheath indicator without using monopolar, with bipolar and scissors. The monopolar device kept breaking down, so it was not available throughout the procedure. Colleagues had contacted phone support and tried everything they could think of; three cables were replaced, a new device was installed, and the system was completely shut down, etc. No alternative energy source, different instrument, or different system configuration of the sort was used to complete the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877582 ↗
• MalfunctionSep 23, 2026Power Problem

  It was reported that during a da Vinci-assisted surgical procedure, user informed the Technical Support Engineer (TSE) that the Patient Side Cart (PSC) displayed a message stating that it was running on battery. The TSE had the user check the breaker on the back of the PSC and the user confirmed it remained in the up position, then had the user verify the system was connected to a known-good outlet that powered other equipment, but the running-on-battery message still displayed. The TSE reviewed the system log and noted that the system logs showed the primary power supply operated below load. The user continued with the procedure using backup battery. No known impact or patient consequence was reported.Intuitive Surgical, (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863990 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 50862370 ↗
• MalfunctionSep 22, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861241 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50848226 ↗
• InjurySep 10, 2026Output Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50724639 ↗
• MalfunctionSep 9, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701654 ↗
• MalfunctionAug 21, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382123 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  A patient in a study underwent a da Vinci-assisted benign hysterectomy and parametrectomy with bilateral salpingo-oophorectomy procedure. The study procedure was completed without intra-operative adverse events and no reported da Vinci device malfunctions. Two days after surgery, it was reported that the patient had post-operative elevated C-reactive protein (CRP). There were no other signs of infections and the event was resolved with antibiotic therapy. There was no prolonged hospitalization and discharge occurred six days after surgery.The study investigator reported the event as mild severity, not a Serious Adverse Event, a Clavien-Dindo Grade II, having a causal relationship to the study procedure, but not related to the patient's underlying disease status, not related to the da Vinci investigational device, and not related to a third-party device. The patient's prior health conditions of COPD and possible pneumonia may be relevant to this incident.

  Patient problems: Unspecified Infection

  MAUDE report 50356680 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear

  It was reported that user informed the Technical Support Engineer (TSE) that error 32100 remained active and did not recover even after an emergency power off was performed. The TSE reviewed the error log and determined it pointed to Single-Port One Axis Manipulator (SOAM) related to the Entry Guide Manipulator (EGM) pitch control hardware on the left-side (SOAM) board. There was no report of patient involvement or patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231315 ↗

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