daVinci X 380620Recalls & reported problems

Summary

The FDA's MAUDE database contains 684 adverse event reports that list this exact device (DI 00886874115404), received between Apr 3, 2020 and Sep 30, 2026 — classified as 41 deaths, 172 injuries, 471 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (273 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 684 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953584 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  It was reported that prior to starting pre anesthesia a da Vinci-assisted surgical simple extraperitoneal prostatectomy procedure, the customer called to report a repeated recoverable error 32100 on Universal Surgical Manipulator (USM) 1. The caller stated that he had recover the error twice, but it kept returning. An Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) reviewed error logs and could confirm error 32100 pointing to Axes Controller, Motor (ACM) on the USM. The TSE guided him to restart the system including Emergency Power-Off (EPO) breakers, but issue remained. TSE informed customer that USM 1 would not be usable. The TSE guided nurse to deactivate USM 1 and explained to her that the system can be used with three arms. Nurse spoke to the responsible surgeon, and the surgery will be cancelled. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942413 ↗
• MalfunctionSep 30, 2026Material Split, Cut or Torn

  It was reported that prior to starting (pre-anesthesia) a da Vinci-assisted surgical procedure, a nurse called in as they have a damaged Blue Fiber Cable that needed to be replaced. The site also asked if they could start a new surgery. The Technical Service Engineer (TSE) explained that they may have a lot of error during the surgery if they start with a cable and for safety reason, it would be safe to not start a new surgery until repair. The procedure was cancelled. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942405 ↗
• MalfunctionSep 28, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926018 ↗
• MalfunctionSep 28, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925195 ↗
• MalfunctionSep 25, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50905543 ↗
• MalfunctionSep 24, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891430 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: Unspecified Infection

  MAUDE report 50889689 ↗
• MalfunctionSep 24, 2026Positioning Problem

  It was reported that prior to starting a da Vinci-assisted surgical procedure using an X system, and before surgical port placement, the Set Up Joint (SUJ) arm 1 Wrist moved without clutching. The customer confirmed no LED indication of a clutched state. A system power cycle was performed, but the issue persisted. As the scheduled procedure was a 3-arm case, the team opted to continue without Arm 1. The procedure was completing as planned.

  Patient problems: Insufficient Information

  MAUDE report 50877567 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 50875937 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50874593 ↗
• MalfunctionSep 23, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50874592 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Anemia; Headache; Low Blood Pressure/ Hypotension

  MAUDE report 50862728 ↗
• MalfunctionSep 22, 2026Visual Prompts will not Clear; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860986 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  A patient in a study underwent a da Vinci assisted Cervixexstirpation with concomitant Douglasplastik surgical procedure. Twenty days after surgery, the patient complained of lower abdominal pain and subsequently presented to an outpatient gynecologist. A hematoma was diagnosed, for which a one-week course of antibiotics and analgesics was initiated. The symptoms improved significantly with this treatment. Currently, the patient is largely asymptomatic, with only mild spotting persisting. A follow-up gynecological examination is still pending; the event is reported as ongoing. The surgical procedure was completed with no intra-operative complications or da Vinci device malfunctions. There were no post-operative complications prior to discharge which occurred the day 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 da Vinci investigational device, not related to the patient's underlying disease status, and not related to a third-party device.

  Patient problems: Abdominal Pain; Hematoma; Unspecified Infection

  MAUDE report 50852849 ↗
• MalfunctionSep 22, 2026Visual Prompts will not Clear

  It was reported that prior to the start of a da Vinci-assisted surgical procedure that non-recoverable fault 32056 occurred against Universal Surgical Manipulator (USM) 4. As system was onsite, The Intuitive Surgical Inc Technical Support Engineer (TSE) reviewed the system logs and found faults against a board inside USM 4. The TSE asked the caller if they would be able to proceed with three USMs; the caller was unsure as the surgeon was not in the room yet. The procedure outcome not provided. The ports were not in place when the issue occurred.ISI contacted the initial reporter and obtained the following information: There was no harm to the patient, and the procedure was aborted to an open procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850381 ↗
• MalfunctionAug 31, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518283 ↗
• DeathAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a da Vinci-assisted inguinal hernia repair procedure, expired on postoperative day #1. The cause of death is currently unknown.Additional information was requested, but the customer did not respond to the follow-up questions. However, the customer indicated that the patient¿s death was unrelated to the robotic "grippers".

  Patient problems: Insufficient Information

  MAUDE report 50289922 ↗
• MalfunctionAug 14, 2026Visual Prompts will not Clear; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263343 ↗
• MalfunctionAug 13, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242948 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A patient in a study underwent a da Vinci assisted sacrocervicopexy with salpingectomy and cystocele repair procedure. Two weeks later, after discharge, the patient developed dysuria and was evaluated by her outpatient gynecologist. Urinalysis confirmed cystitis. Treatment consisted of fosfomycin 3g, a single dose, resulting in improvement of the symptoms. There were no further medical interventions and the event was reported as resolved the next day. There was no report of intra-procedure complications, da Vinci device malfunctions or post-procedure complications prior to discharge after the index surgical procedure.The study investigator reported the event as mild severity, not a Serious Adverse Event, a Clavien-Dindo Grade II, possibly related to the study procedure, possibly related to the patient's underlying disease status, but not related to the da Vinci investigational device, and not related to a third-party device. The patient's prior health conditions of diabetes and surgery may be relevant to this incident.

  Patient problems: Urinary Tract Infection

  MAUDE report 50229725 ↗
• MalfunctionAug 12, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218039 ↗
• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a da Vinci-assisted hepatic lobectomy procedure, developed post-hepatectomy liver failure and expired. The patient was Child-Pugh Class A. There were no intraoperative complications, and the procedure was successfully completed robotically. The surgery involved parenchymal resection, described as approximately 10% non-anatomical resection. The suspected cause of deterioration was portal vein thrombosis that progressed to ischemic hepatitis, accompanied by refractory acidosis and a rising International Normalized Ratio (INR). Despite Intensive Care Unit level support and other unspecified interventions, the patient expired on postoperative day 2. Attempts were made to obtain additional information from the surgeon; however, no additional information was received.

  Patient problems: Liver Failure; Metabolic Acidosis; Thrombosis/Thrombus

  MAUDE report 50211711 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information

  It was reported that after a patient underwent a da Vinci-assisted emergency gallbladder procedure. The procedure was completed as planned and no device issue or malfunction was reported. Two days post-operatively, the patient experienced bleeding that necessitated a return to the operating room. Upon surgical exploration, no identifiable source of bleeding was found, as the bleeding had ceased by the time of intervention. No further hemorrhage control measures were required.Intuitive Surgical, Inc. (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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50117850 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  A patient in a study underwent a da Vinic assisted pulmonary segmentectomy. Two days later, it was reported that the patient experienced an atrial arrhythmia and was prescribed bisoprolol and enoxaparin as treatment; a cardiologist consult will be performed. The event is reported as ongoing. There were no intra-procedure complications and no da Vinci device malfunctions. Discharge occurred four days after surgery without a prolonged hospitalization. The study investigator reported the event as severe, a Serious Adverse Event, a Clavien-Dindo Grade II, possibly related to the patient's underlying disease status, but not related to the da Vinci study device, and not related to the procedure.

  Patient problems: Arrhythmia

  MAUDE report 50114755 ↗