daVinci Si 380614Recalls & reported problems

Summary

The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 00886874110690), received between Mar 25, 2020 and Aug 26, 2026 — classified as 12 deaths, 54 injuries, 205 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (72 reports).

1 FDA recall record name this device's identifier.

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. Jul 16, 2018Terminated

   Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

   Z-3254-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, the customer called a Field Service Engineer (FSE) and reported that the system had an error 25596 on the Armnet1 Remote Arm Controller 1 (RAC1). The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: Error could not be resolved, arm1 disabled, they continued and completed the procedure with two remaining arms, in the original configuration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50445764 ↗
• MalfunctionAug 11, 2026Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, the customer called an ISI Technical Support Engineer (TSE) and reported a non-recoverable error 22023 on the Patient Side Manipulator (PSM). The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: Error was not resolved; the site continued and completed the procedure with two arms. The system was still in the original configuration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215063 ↗
• DeathJul 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PARTIAL NEPHRECTOMY FOR TUMOR REMOVAL, THE PATIENT¿S RENAL ARTERY WAS DAMAGED; ALTHOUGH THE ARTERY WAS REPAIRED, POST-OPERATIVE BLEEDING OCCURRED AND THE PATIENT EXPIRED. THE SOURCE OF THE INFORMATION WAS FROM UNSPECIFIED MEDIA COVERAGE OF THE EVENT. THE UNCONFIRMED SOURCE DATA REPORTED THAT THE BLEEDING VESSEL WAS SUTURED, BUT THE SUTURE THREAD BROKE, RESULTING IN FEWER LIGATIONS (2-3 TIMES) THAN NORMAL. ADDITIONAL SUTURES WERE PERFORMED AFTER THE BREAKAGE, BUT THE HEMOSTASIS WAS STILL INSUFFICIENT WHICH LED TO POST-OPERATIVE BLEEDING. THE PATIENT¿S POST-OPERATIVE CONDITION WORSENED. THE PATIENT RECEIVED ADDITIONAL INTERVENTIONS, INCLUDING KIDNEY REMOVAL AND BLOOD TRANSFUSIONS. THE PATIENT EXPIRED FROM HEMORRHAGIC SHOCK ON POST-OPERATIVE DAY ONE. THE SOURCE OF THE INFORMATION WAS FROM UNSPECIFIED MEDIA COVERAGE OF THE EVENT. THE HOSPITAL REPORTS THAT THEY INVESTIGATED THE EVENT AND CONCLUDED THE CAUSE OF DEATH WAS RE-BLEEDING AS A RESULT OF LOOSENING OF THE SUTURES AT THE HEMOSTASIS SITE. THE HOSPITAL PLANS TO IMPLEMENT A SYSTEM WHERE MULTIPLE PHYSICIANS CONFIRM HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25713093 ↗
• MalfunctionMay 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING THE HARMONIC ACE BEING UNABLE TO ROTATE. TSE GUIDED THE CUSTOMER TO RESEAT THE HARMONIC ACE AND THE STERILE ADAPTER. THE CUSTOMER NOTED THAT THE REPORTED COMPLAINT REMAINED. TSE INSTRUCTED THE CUSTOMER TO POWER CYCLE THE DA VINCI SYSTEM WHEN IT WAS CONVENIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212260 ↗
• MalfunctionMay 11, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 31020 WAS TRIGGERED. A POWER CYCLE WITH EMERGENCY POWER OFF (EPO) DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25143696 ↗
• MalfunctionApr 29, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN SI SYSTEM, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 17 APPEARED WHEN THE SYSTEM WAS POWERED ON. THE SITE REBOOTED THE SYSTEM, BUT THE ISSUE PERSISTED. THE USER PROVIDED ERROR DETAILS, AND TSE IDENTIFIED ADDITIONAL ERRORS THAT INDICATED A PROBLEM ASSOCIATED WITH THE PATIENT SIDE CART (PSE), LEADING TO GUIDANCE TO RESET THE POWER CABLE AND THE BLUE FIBER CABLE FOR THAT COMPONENT. AFTER THESE STEPS WERE FOLLOWED AND THE SYSTEM WAS REBOOTED, A NEW ERROR 802 APPEARED, AND TSE THEN ADVISED CHECKING THE EMERGENCY POWER-OFF CIRCUIT, BUT THIS DID NOT RESTORE NORMAL OPERATION. THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC APPROACH. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036991 ↗
• MalfunctionApr 17, 2026Output Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A RECOVERABLE ERROR 23023 OCCURRED ON THE PATIENT SIDE MANIPULATOR (PSM)3. TSE LEARNED THAT THE USER HAD POWER CYCLED THE SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917881 ↗
• MalfunctionApr 15, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ERROR 25580. POWER CYCLING THE SYSTEM DIDN'T FIX THE ISSUE. THE CUSTOMER USED PATIENT SIDE MANIPULATOR (PSM) 2 AND PSM 3 TO CONTINUE THE PROCEDURE. THIS ISSUE WAS PREVIOUSLY REPORTED AND HAS RETURNED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DISABLED THE USE OF ARM DUE TO THE ISSUE. THE PROCEDURE DATE WAS (B)(6) 2026. THE SURGEON WAS DR. WANG, AND THE PROCEDURE WAS A RADICAL PROSTATECTOMY. THE PROCEDURE WAS COMPLETED WITH TWO ARMS SINCE PSM 1 WAS DISABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890785 ↗
• MalfunctionApr 3, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE TRANSABDOMINAL PROSTATECTOMY SURGICAL PROCEDURE, PATIENT SIDE MANIPULATOR (PSM) 1 COULD NOT GRASP TISSUE WELL. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED RESEATING THE STERILE ADAPTER (SA). THE CALLER STATED THAT IT HAD NOT WORKED. THE PROCEDURE WAS COMPLETED. THE CALLER HADN'T NOTICED ERRORS OR ANY MESSAGE INFO APPEARED. 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 NOTED SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND IT POWERED ON WITHOUT ANY ERRORS. SITE RE-INSTALLED THE STERILE ADAPTER AND INSTRUMENT TWICE TO CONTINUE THE PROCEDURE AND CONTINUED TO USE THE ARM#1 AND ARM#2 TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED TO THE PATIENT. THE SURGEON DID NOT DISABLE ARM#1. THE PROCEDURE COMPLETED ROBOTICALLY WITH 3 ARMS AND DID NOT NEED TO USE THE ARM#3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783899 ↗
• MalfunctionApr 3, 2026Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783680 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL URETHROPLASTY PROCEDURE, THE SYSTEM REPORTED ERROR 816 WHEN THE CUSTOMER DROVE THE PATIENT SIDE CART (PSC). THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM, BUT THE ISSUE REMAINED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721138 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ERRORS 1 AND 816. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710056 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, FAULT 22003 OCCURRED ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CALLER TO CHECK THE ERROR LOGS AND CONFIRMED AN ERROR 22003, INDICATING P1=0 POINT TO SJC AXIS 1. POWER CYCLING THE SYSTEM COULD NOT FIX THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24709894 ↗
• MalfunctionMar 30, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM THE CUSTOMER INFORMED THE FIELD SERVICE ENGINEER (FSE) ABOUT NON-INTUITIVE MOVEMENT DURING THE LAST PROCEDURE WITH SYSTEM. THIS SYSTEM IS NOT FOR HUMAN USE AND CUSTOMER SAID THAT THERE WAS NO DELAY DURING THE LAST USAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709713 ↗
• MalfunctionMar 26, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO INSTALL AN INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR 2 (USM2). THE TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO TEST THE INSTRUMENT ON ANOTHER USM AND FOUND IT ENGAGED CORRECTLY. THE CUSTOMER THEN TRIED TO RESEAT THE STERILE ADAPTER ON THE USM2 BUT THE ISSUE REMAINED. THE CUSTOMER CONTINUED THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695707 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROCEDURE, THE PATIENT SUSTAINED A BOWEL OBSTRUCTION. THE SURGEON DOES NOT RELATE THE PATIENT'S POSTOPERATIVE BOWEL OBSTRUCTION TO THE INITIAL ROBOTIC PROCEDURE. THE SPECIFICS OF THE PATIENT'S COMPLICATION ARE UNKNOWN. THE PATIENT WAS TREATED FOR THE BOWEL OBSTRUCTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24630456 ↗
• MalfunctionMar 4, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24508760 ↗
• MalfunctionMar 2, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE CONTACTED TECHNICAL SUPPORT TO REPORT AN ISSUE THAT THE PATIENT SIDE MANIPULATOR (PSM) 1 CANNULA MOUNT WAS DEFECTIVE AND COULD NOT SECURE THE CANNULA PROPERLY. THE SITE CONTINUED THE PROCEDURE USING PSM 2 AND PSM 3. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478736 ↗
• MalfunctionFeb 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE START (POST-ANESTHESIA) OF A DA VINCI-ASSISTED SURGICAL PROCEDURE AND DURING DRAPING, PATIENT SIDE MANIPULATOR (PSM) 1 LINK 6 CAP WAS FOUND DAMAGED. THE CUSTOMER COULD NOT CONTINUE THE PROCEDURE WITH TWO PSM ARMS; THEREFORE, THE SURGEON ELECTED TO ABORT THE DA VINCI PROCEDURE AND CONTINUE WITH LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471652 ↗
• MalfunctionFeb 26, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24452645 ↗
• InjuryFeb 12, 2026Insufficient Device Problem Information

  A REVIEW OF AN ARTICLE THAT INVESTIGATED THE IMPACT OF VARIOUS RISK FACTORS ON SURGICAL OUTCOMES AND TO IDENTIFY THE MOST EFFECTIVE SURGICAL APPROACH FOR PERFORMING ROBOTIC HYSTERECTOMY (RH) WAS PERFORMED. THE ARTICLE DESCRIBES A FEW NON-SPECIFIC INTRA-OPERATIVE COMPLICATIONS WITH MINIMAL DETAILS. A TOTAL OF 4 INCIDENTS OF ORGAN INJURIES WERE RECORDED. ONE PATIENT EXPERIENCED A BLADDER INJURY, AND THREE PATIENTS EXPERIENCED VAGINAL LACERATIONS, ALL OF WHICH REQUIRED INTRAOPERATIVE REPAIR WITHOUT SUBSEQUENT COMPLICATIONS. ADDITIONALLY, 6 CASES NECESSITATED INTRAOPERATIVE BLOOD TRANSFUSIONS. POST-OPERATIVELY, ONE PATIENT SUFFERED A CUFF INFECTION AND URINARY TRACT INFECTION REQUIRING ANTIBIOTIC THERAPY, AND ANOTHER PATIENT EXPERIENCED CUFF DEHISCENCE AND BLEEDING LEADING TO READMISSION AND RESOLUTION AFTER SECONDARY SUTURE, AND ONE PATIENT EXPERIENCED URINARY RETENTION REQUIRING CATHETERIZATION FOR 2 WEEKS. ELEVEN CASES REQUIRED POSTOPERATIVE BLOOD TRANSFUSIONS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMA

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

  MAUDE report 24329497 ↗
• MalfunctionFeb 6, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, A CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT PATIENT SIDE MANIPULATOR (PSM) #2 CANNULA MOUNT WAS LOOSE WITH AN ERROR MESSAGE. THE CUSTOMER USED THE OTHER PSM ARMS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275593 ↗
• MalfunctionFeb 5, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM THE CUSTOMER CALLED TO REPORT THAT REPEATED NON-RECOVERABLE FAULT 802 OCCURRED ON BOOTUP. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM HARD POWER-CYCLE WITH EMERGENCY POWER OFF (EPO). HOWEVER, THE ISSUE REMAINED. ONSITE IS NOT CONNECTED AT THE TIME. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271205 ↗
• MalfunctionJan 29, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206848 ↗
• MalfunctionJan 26, 2026Optical Problem

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE LAMP WAS EXPIRED WITH ERROR 48246. TSE GUIDED THE CUSTOMER TO REPLACE THE LAMP, BUT THEY DIDN'T HAVE A BACKUP LAMP. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184513 ↗