da Vinci SP 380601Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00886874114605), received between Jul 10, 2020 and Sep 25, 2026 — classified as 9 deaths, 126 injuries, 151 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (60 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 18, 2026.

Recalls naming this device

1. Apr 22, 2026Class IIOpen, 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, 2024Class IIOpen, 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 problems

Recent adverse event reports

The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

• 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 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 21, 2026Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50848226 ↗
• MalfunctionSep 9, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701654 ↗
• 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 ↗
• MalfunctionAug 11, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50216076 ↗
• MalfunctionAug 11, 2026Physical Resistance/Sticking

  It was reported during training/demo that the Boom had not been retracting or extending properly. The caller stated that the system had not been going into sterile stow and also stated that the Entry Guide Manipulator (EGM) had not been rotating 360 degrees. There was no report of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203249 ↗
• MalfunctionJul 30, 2026No Device Output

  Patient problems: Insufficient Information

  MAUDE report 50092819 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  A patient in a study underwent a da Vinci-assisted benign hysterectomy procedure. On the first postoperative day, an increased volume of bloody fluid was noted at the drainage. An ultrasound evaluation revealed a hematoma in the Douglas pouch measuring 78 x 38 x 82 mm. The patient reported increasing dizziness, and laboratory tests showed a declining hemoglobin level, leading to the decision to initiate treatment. This revealed a hemoperitoneum with a volume of approximately 600 ml. A small source of bleeding on the greater omentum was coagulated, and the area was thoroughly irrigated; there was no blood transfusion. The event led to a prolonged hospitalization; discharged occurred 4 days after surgery.The study investigator reported the event as mild severity, not a Serious Adverse Event, a Clavien-Dindo Grade IIIb, possibly related to the study procedure and possibly related to the patient's underlying disease status.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50072048 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after a da Vinci-assisted Single Port (SP) pulmonary segmentectomy procedure, the patient developed a post-operative diaphragmatic hernia resulting in an additional surgical procedure to repair. The procedure was completed and the patient is in stable condition.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: Unspecified Tissue Injury

  MAUDE report 50059999 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON POST-OPERATIVE DAY 1, FOLLOWING A DA VINCI-ASSISTED SINGLE PORT (SP) THYMECTOMY PROCEDURE FOR MYASTHENIA GRAVIS, THE PATIENT EXPERIENCED A POST-OPERATIVE HEMORRHAGE RESULTING IN AN OPEN RE-OPERATION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) IN CRITICAL STATE AFTER THE RE-OPERATION. CURRENTLY, THE PATIENT IS STILL IN THE HOSPITAL RECOVERING. IN REGARDS TO THE REPORTED EVENT, THE SURGEON STATED, "THIS WAS NOT CONSIDERED TO BE DUE TO ANY DEFECT IN THE SP SYSTEM."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 25262967 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED SACROCOLPOPEXY AND COLPORRHAPHY SURGICAL PROCEDURE. ON POST-OPERATIVE DAY TWO, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED A HYPERTENSIVE CRISIS. THERE WAS A CARDIOLOGY CONSULT AND THE PATIENT'S HYPERTENSION MEDICATION WAS ADJUSTED TO HIGHER DOSES OF ENALAPRIL. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS; IT WAS REPORTED THERE WERE NO DA VINCI DEVICE MALFUNCTIONS. THE EVENT WAS REPORTED AS RESOLVED THREE DAYS LATER; DISCHARGE TO HOME OCCURRED THE SAME DAY. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, NOT RELATED TO THE STUDY PROCEDURE, 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 CONDITION OF KNOWN HYPERTONIA MAY BE RELEVANT TO THIS INCIDENT.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 25243422 ↗
• MalfunctionMay 19, 2026Output Problem

  IT WAS REPORTED THAT ERROR 25748 OCCURRED WHEN THE CALLER BEGAN DRAPING THE SYSTEM. THE CUSTOMER POWER CYCLED THE SYSTEM SEVERAL TIMES, BUT THE ISSUE REMAINED. THE TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH A HARD POWER CYCLE OF THE SYSTEM, AND INSTALLING A CANNULA INTO THE MOUNT TO SEE IF THE SYSTEM COULD GET PAST THE INITIALIZATION, BUT THERE WAS NO RESOLUTION. NO FURTHER TROUBLESHOOTING WAS PERFORMED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223923 ↗
• MalfunctionMay 18, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE PATIENT SIDE CART (PSC) REPEATEDLY FAULTED. AT THE TIME OF THE FAULT THE PSC WAS BEING BROUGHT INTO THE ROOM TO BE CONNECTED TO THE REST OF THE SYSTEM. WHEN THE SYSTEM WAS POWERED ON, REPEATED 23022 ERRORS OCCURRED. THE PSC COULD NOT BE DRIVEN EITHER. THE CUSTOMER POWER CYCLED THE SYSTEM AND TRIED TO RECOVER THE FAULT SEVERAL TIMES, BUT THE FAULT RETURNED. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM A HARD POWER CYCLE OF THE PSC, BUT THE FAULT RETURNED. THE CUSTOMER USED A DIFFERENT PSC FOR THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197068 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT SIDE MANIPULATOR (PSM2) WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT INVOLVEMENT DUE TO SYSTEM SP0016 IS NOT FOR HUMAN USE.

  Patient problems: Insufficient Information

  MAUDE report 25168366 ↗
• MalfunctionMay 6, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON OBSERVED THE HALO ROTATED UNEXPECTEDLY. THERE WERE NO ERRORS REPORTED ON THE SYSTEM AND NO FURTHER INFORMATION WAS AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100893 ↗
• MalfunctionMay 5, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE WITH SINGLE-PORT (SP) DA VINCI SYSTEM, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT PATIENT SIDE CART (PSC) BOOM WAS NOT STABLE IN THE X-AXIS. THE TSE COULD NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE ADVISED THE CUSTOMER TO POWER CYCLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS NOT RESOLVED DURING THE PROCEDURE. THE BOOM WAS STILL MOVING WHEN THE CUSTOMER TRIED TO MOVE IT WITHOUT PRESSING ANY CLUTCH OR FORCE. THE ISSUE CAUSED UNCONTROLLED MOTION OF THE INSTRUMENT WHEN THE CUSTOMER TOUCHED THE BODY OF THE ROBOT TO CHANGE AN INSTRUMENT OR CLEAN UP THE ENDOSCOPE. THE ISSUE DID NOT AFFECT THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085903 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE SUSTAINED A FOOT INJURY MANEUVERING THE PATIENT SIDE CART (PSC). THE NURSE WAS POSITIONED ADJACENT TO THE CART AND HELD THE HANDLEBAR TO PUSH IT FORWARD. DURING THIS ACTION, THE NURSE'S FOOT BECAME TRAPPED UNDER ONE OF THE CART¿S WHEELS, RESULTING IN AN INJURY. THE INJURY DID NOT RESULT IN ANY FRACTURES, BUT THE NURSE REQUIRED UNSPECIFIED MEDICAL INTERVENTION AND TWO WEEKS OF RECOVERY. THE NURSE¿S CURRENT CONDITION WAS NOT PROVIDED.

  Patient problems: Crushing Injury

  MAUDE report 25045005 ↗
• MalfunctionApr 28, 2026Material Integrity Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM3) WAS DAMAGED DURING REMOVAL OF THE STERILE ADAPTER. TSE REQUESTED PHOTOS OF THE DAMAGE FROM THE USER. AFTER THE PHOTOS WERE RECEIVED AND REVIEWED, TSE DETERMINED THAT USM3 WOULD NOT BE FUNCTIONAL DUE TO THE OBSERVED DAMAGE. THE PROCEDURE WAS COMPLETED AS PLANNED USING THE ORIGINAL SYSTEM CONFIGURATION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022504 ↗
• MalfunctionApr 23, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ARM HAD AN UNEXPECTED ARM MOTION DURING PROCEDURE. HE CONCLUDED THAT IT COULD BE USER ERROR BUT WOULD LIKE A FULL CALIBRATION AND VERIFICATION OF THE SYSTEM SPECIFICALLY MASTER TOOL MANIPULATOR (MTM) GRAVITY AND ENTRY GUIDE MANIPULATOR (EGM) TESTING. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED THE SURGEON STILL HAS CONCERNS AND THEY HAVE BEEN ESCALATED TO OUR PRODUCT SUPPORT TEAM.

  Patient problems: Insufficient Information

  MAUDE report 24973492 ↗
• MalfunctionApr 21, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS RECOVERABLE FAULT 25748 DURING SYSTEM STARTUP. THE CUSTOMER PRESSED 'RECOVER'; HOWEVER, THE SAME ISSUE PERSISTED. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946231 ↗
• MalfunctionApr 21, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, PATIENT SIDE MANIPULATOR (PSM) 1 WAS NOT CONTINUOUSLY DRAPED. THE DISC AND DRAPE OF THE FIRST ARM ARE CONNECTED SO THAT THE DISC SHOULD ROTATE, BUT THE DISC DID NOT ROTATE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER EXERCISE THE PRESENCE PINS ON THE PSM AND TRY THE STERILE ADAPTER, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABORTED PRIOR TO PORT PLACEMENT; THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT PSM1 WAS THE PROBLEM, SO PSM 1 WAS REPLACED AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938308 ↗