daVinci Si 380686Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00886874110775), received between Sep 25, 2020 and Apr 7, 2026 — classified as 1 death, 5 injuries, 23 malfunctions.

The most frequently reported specific device problem is “No Device Output” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026No Device Output

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE TECHNICAL SERVICE ENGINEER (TSE) TO INFORMED THAT ARM 2 WAS NOT FREE TO MOVE. NO RECOVERABLE FAULTS WERE DISPLAYED. AT THE TIME OF THE CALL, THE CSR PERFORMED A SYSTEM RESTART, INCLUDING EMERGENCY POWER OFF (EPO). THE CSR CONFIRMED THAT THE SYSTEM STARTED UP WITHOUT FAULTS AND THE ISSUE OCCURRED AFTER AN INSTRUMENT REPLACEMENT. AFTER ATTEMPTS TO RECOVER, THE PROBLEM PERSISTED. THE CSR WAS ABLE TO MOVE ARM 3 FOR ARM 2 POSITION TO PROCEED WITH TRAINING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812036 ↗
• MalfunctionMar 30, 2026No Device Output

  IT WAS REPORTED THAT PRIOR TO STARTING ¿ PRE ANESTHESIA OF A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED STERILE ADAPTER IS NOT DETECTING ON ARM 3. THE SITE WAS PROCEEDING THE SURGERY BY ABANDONING THE ARM 3. THE SITE TRIED CHANGING THE DRAPE. THE TSE SUGGESTED THE CUSTOMER CLEAN THE POGO PINS ON THE ARM 3 AND TRY AGAIN. THE CUSTOMER INFORMED THEY WOULD DO THE CHECK AFTER THE PROCEDURE COMPLETION. THE SYSTEM WAS NOT CONNECTED TO ONSITE DURING TIME OF CALL. THE CUSTOMER CALLED BACK AND CONFIRMED THE ISSUE IS NOT RESOLVED BY THE TROUBLESHOOTING RECOMMENDED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710146 ↗
• MalfunctionDec 8, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751380 ↗
• MalfunctionDec 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO THE START (POST-ANESTHESIA) OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THERE WAS RESISTANCE FELT AT THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1 INSERTION AXIS, EVEN WITHOUT A DRAPE BEING ATTACHED. THE ARM WAS ABANDONED AND THE PROCEDURE WAS REPORTEDLY BEING COMPLETED AS PLANNED. THERE WERE NO REPORTS OF THE PORTS ALREADY BEING IN PLACE WHEN THE ISSUE OCCURRED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER ADVISED THAT THE SYSTEM WAS ALREADY DOCKED WHEN THE REPORTED ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699142 ↗
• MalfunctionOct 15, 2025Positioning Problem; Positioning Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280668 ↗
• MalfunctionMay 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, REPEATED NON-RECOVERABLE ERROR 25580 OCCURRED ON ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). TSE HAD SITE PERFORM A HARD POWER CYCLE ON THE SYSTEM, BUT REPEATED NON-RECOVERABLE ERROR 40006 POINTING TO REMOTE ARM CONTROLLER BOARDS (RAC) 3 OF THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) OCCURRED AFTER THE HARD POWER CYCLE. TSE HAD SITE PERFORM POWER CYCLE THE SYSTEM ONE MORE TIME, BUT THE ISSUE PERSISTED. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION AND NO ADDITIONAL PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101204 ↗
• MalfunctionNov 19, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ARM 2 DID NOT WORK ANYMORE. THE CUSTOMER STATED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS INSTALLED AND THE LEDS ON PATIENT SIDE MANIPULATOR (PSM) 2 WERE AMBER WITHOUT AN ERROR CODE ON THE TOUCHSCREEN. PRIOR TO THE CALL TO TECHNICAL SUPPORT, THE CUSTOMER HAD REPLACED THE INSTRUMENT AND RESEATED THE STERILE ADAPTER (SA). THE TSE CHECKED THE LOGS AND FOUND 31010 AND 282 ERRORS INDICATING INSTRUMENT SENSOR ISSUES. THE TSE REQUESTED THE CUSTOMER TO REPLACE THE DRAPE ON ARM 2 WITHOUT IMPROVEMENT. THE PSM 2 WAS NOT ENGAGED WITH THE SA. THE TSE GUIDED THE CUSTOMER TO CHECK THE POGO PINS AND PSM WRIST INPUT COG, BUT NO PHYSICAL DAMAGE WAS FOUND. THE TSE ASKED CUSTOMER TO PERFORM A HARD POWER CYCLE WITH AN EMERGENCY POWER OFF (EPO) BUT GOT THE SAME RESULT. THE TSE ASKED THE SURGEON IF SHE COULD PROCEED WITH 3 ARMS, WHICH WAS THE CASE. THE SURGERY WAS RESUMED. THE CUSTOMER WOULD POSTPONE THE SURGERY OF THIS AFTERNOON, BUT THE CUSTOMER NEEDED THEIR FIELD SERVICE ENGINEER (FSE) TO RESOLVE THE ISSUE AS SOON AS POSSIBLE DUE TO ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726318 ↗
• MalfunctionJul 1, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON DISABLED THE ARM AND PROCEEDED WITH THE PROCEDURE AFTER AN ERROR IN ARM 3. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED TO THE CLINICAL ENGINEER SOME TROUBLESHOOTING STEPS, BUT THE CALLER DECLINED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENGINEERING TECHNICIAN REPORTED THAT THE SYSTEM WAS CONNECTED WITHOUT ERRORS, THE FAILURE OCCURRED AFTER THE START OF THE PROCEDURE. PATIENT INFORMATION WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652066 ↗
• MalfunctionJun 14, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INSTRUMENT WAS NOT DETECTING ON ARM 2 AND THAT THE SITE OBSERVED THAT THE STERILE ADAPTER CLAMP WAS NOT INTACT. THE CUSTOMER TRIED PRESSING THE INSTRUMENT AGAINST THE ARM. FINALLY, THE CUSTOMER ABANDONED ARM 2 AND CONTINUED THE SURGERY AS PLANNED. THE TSE FOUND NO ERROR IN THE LOGS RELATED TO ARM 2. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541486 ↗
• MalfunctionMay 23, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE MONOPOLAR CURVED SCISSORS (MCS) WERE NOT WORKING IN UNIVERSAL SURGICAL MANIPULATOR 3 (USM). THE ISI TSE ASKED THE CUSTOMER TO SWAP THE INSTRUMENT IN USM 3 TO USMS 1 AND 2; IT WORKED FINE IN THE OTHER USMS. THE ISI TSE ASKED THE CUSTOMER TO SWAP THE INSTRUMENTS IN USMS 1 AND 2 TO USM 3; OTHER INSTRUMENTS DID NOT WORK IN USM 3. THE ISI TSE SUGGESTED CLEANING THE PINS ON THE USM 3 AND RESETTING THE DRAPE, BUT THE ISSUE STILL PERSISTED. THE ISI TSE ADVISED PERFORMING A FULL POWER CYCLE, BUT THE CUSTOMER REFUSED AS THE SURGERY WAS GOING ON. THE CUSTOMER WAS PROCEEDING WITH SURGERY ON THE REMAINING TWO USMS. THE SITE WAS COMPLETING THE PROCEDURE AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388703 ↗
• MalfunctionApr 30, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER HAD RECOVERABLE FAULT ON THE PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER REPORTED THAT BEFORE DOCKING THE SYSTEM DISPLAYED THE ERRORS 10025, 25553, 31004 RECOVERABLE FAULTS AND THE NON-RECOVERABLE FAULT 252. THE CUSTOMER RESTARTED THE SYSTEM AND DISABLED THE PSM3 AND START THE DOCKING WITH JUST TWO ARMS. THE SYSTEM PRESENTED THE ERRORS ON STARTUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE PLACED PRIOR TO ISSUE BEING IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218287 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVIEW OF A LITERATURE ARTICLE INVOLVING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY, THE FOLLOWING INCIDENT WAS NOTED. AFTER THE SUTURING FOR THE VESICOURETHERAL ANASTOMOSIS, ONE NEEDLE WAS NOTED MISSING DURING REMOVAL THROUGH 12MM CANNULA. A SEARCH USING THE DA VINCI SYSTEM WAS PERFORMED IN THE ABDOMINAL CAVITY, BUT THE NEEDLE WAS NOT FOUND. THE DA VINCI SYSTEM WAS THEN UNDOCKED AND THE NEEDLE WAS FOUND ATTACHED TO THE ABDOMINAL WALL USING LAPAROSCOPIC ENDOSCOPE AND WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19052424 ↗
• MalfunctionMar 28, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIORRHAPHY AND VASECTOMY SURGICAL PROCEDURE, THE SYSTEM GAVE A RECOVERABLE FAULT IN THE PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER RECOVERED THE FAULT BY DEACTIVATING THE ARM. THE CUSTOMER MOVED THE INSTRUMENT FROM PSM3 TO PSM2 TO CONTINUE WITH THE PROCEDURE AND THE INSTRUMENT WAS NOT RECOGNIZED, THE CUSTOMER DECIDED TO RESTART THE SYSTEM. AFTER RESTARTING, THE ISSUE IN THE PSM3 WAS SOLVED, THE CUSTOMER PLUGGED THE SAME INSTRUMENT IN THE PSM2 AND AGAIN THE INSTRUMENT WAS NOT RECOGNIZED. THE CUSTOMER CHANGED THE INSTRUMENT AND PUT A NEW ONE IN THE PSM3. THE ENGAGEMENT WAS SUCCESSFUL AND THE CUSTOMER DECIDED CONTINUE WITH TWO ARMS, PSM1 AND PSM3. AFTER THESE ACTIONS, THE CUSTOMER CALLED THE FIELD SERVICE ENGINEER (FSE) FOR AN ERROR ANALYSIS. THE FSE GUIDED THE CUSTOMER TO CONNECT THE SYSTEM IN THE ONSITE. DURING THE PHONE CALL NO ERRORS WERE OBSERVED. THE FSE CONTINUED TO ANALYZE THE LOGS UNTIL THE END OF THE PROCEDURE AND NO MORE ERRORS ARE OBSERVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND TECHNICAL CONSULTANT OBTAINED THE FOLLOWIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991925 ↗
• MalfunctionJun 5, 2023No Apparent Adverse Event; Physical Resistance/Sticking; No Apparent Adverse Event; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) WITH CLAMP HAD AN INSERTION FAILURE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM POWERED ON WITHOUT ERRORS AND SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE CLINICAL SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE AND CONTACTED SUPPORT WHEN THE ISSUE OCCURRED. THE FSE PROVIDED TROUBLESHOOTING ON HOW TO RECOVER FROM THE REPORTED PROBLEM, BUT THE ISSUE PERSISTED. THE FSE ADVISED THAT THE AFFECTED PSM COULD BE DISABLED ALLOWING THE USER TO COMPLETE THE PROCEDURE WITH THE REMAINING ARMS; HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067482 ↗
• MalfunctionJun 5, 2023Positioning Failure; Visual Prompts will not Clear; Positioning Failure; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A RECOVERABLE ERROR 23021 OCCURRED AND THE PATIENT SIDE MANIPULATOR (PSM) 3 WAS UNABLE TO MOVE. THE CUSTOMER POWER-CYCLED THE SYSTEM; HOWEVER, THE ERROR PERSISTED. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES WHICH WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS; HOWEVER, ERRORS OCCURRED DURING THE PROCEDURE. THE CUSTOMER CONTACTED SUPPORT AND FULL TROUBLESHOOTING WAS COMPLETED. THE CUSTOMER MANUALLY EXERCISED THE PSM AND POWER-CYCLED; HOWEVER, THE ERROR PERSISTED. THE FSE GUIDED THE CUSTOMER TO DISABLE TO AFFECTED PSM SO THE PROCEDURE COULD BE COMPLETED ROBOTICALLY WITH PSM 1 AND PSM 2; HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO LAPAROSCOPIC TECHNIQUES AND WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067478 ↗
• InjuryJun 2, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) TURNED TO BATTERY MODE. THE FIELD SERVICE ENGINEER (FSE) WAS AT THE SITE FOR A CASE OBSERVATION AND HAD PERFORMED A HARD POWER CYCLE TO MAKE THE SYSTEM READY FOR USE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND REVIEWED THE ERROR AND FOUND 817. THE TSE STATED THE AUXILLARY POWER BOARD (APB) OR MEDICAL GRADE POWER SUPPLY (MGPS) MAY HAVE MALFUNCTIONED DURING THE TIME OF EVENT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE. THE PSC SWITCHED TO BATTERY MODE AND UNABLE TO BRING TO NORMAL MODE. NO TROUBLESHOOTING WAS PERFORMED WITH DVSTAT. THERE WERE NO ISSUES NOTED DURING SET UP OF THE SYSTEM AND THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ISSUES WITH THE PORT PLACEMENT(S) AND THE SURGICAL STAFF DID NOT OBSERVE THAT THERE WERE ANY OUTSIDE INFLUENCES THAT WERE IMPEDING MOVEMENT OF THE SYSTEM / PATIENT SIDE MANIPULATORS (PSM). TROUBLESHOOTING STEPS WERE PERFORMED WITH THE FSE BUT TECHNICAL SUPPORT WAS NOT INVO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046173 ↗
• MalfunctionMay 22, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER AN INSTRUMENT WAS INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) 3, THE PSM STOPPED RESPONDING, PRESENTED A YELLOW FAULT, AND A MESSAGE "ARM NOT FREE TO MOVE." AFTER REBOOTING AND REMOVING THE INSTRUMENT, THE FAULT CONTINUED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971726 ↗
• MalfunctionMay 17, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE ARM1 WAS LOCKED AND WOULD NOT MOVE WHEN STARTING THE ROBOTIC SYSTEM. A MESSAGE WAS DISPLAYED THAT "ARM1 WAS NOT FREE TO MOVE". THERE WAS ERROR 25326 ON PATIENT SIDE MANIPULATOR (PSM) 1 / REMOTE ARM CONTROLLER (RAC) 1. 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 SURGEON DISABLED AND/OR DISCONTINUED THE USE OF THE ARM DUE TO THE ISSUE. THE PROCEDURE WAS NOT COMPLETED WITH FOUR ARMS. THE ARM THAT PRESENTED THE PROBLEM WAS DEACTIVATED AND THE PROCEDURE CONTINUED WITH THE OTHER ARMS. THE CUSTOMER DID NOT ANSWER IF PORTS WERE PLACED AT THE TIME OF THE ISSUE. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CUSTOMER INACTIVATED THE ARM WITH THE PROBLEM AND THE PROCEDURE CONTINUED WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING THE SAME SYSTEM. PATIENT INFORMATION WAS REQUESTED BUT COULD NOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950870 ↗
• MalfunctionApr 12, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OROPHARYNGECTOMY SURGICAL PROCEDURE, THE ARM 2 MOVED UNEXPECTEDLY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722135 ↗
• MalfunctionMar 10, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526715 ↗
• MalfunctionFeb 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308777 ↗
• MalfunctionJan 24, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237938 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO-OOPHORECTOMY SURGICAL PROCEDURE, THE PROCEDURE WAS GOING WELL; HOWEVER, THE PATIENT HAD A LOT OF ADHESIONS AND FOUND THE UTERUS WAS VERY ATTACHED TO THE INTESTINE SO THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN. THIS WAS THE PATIENT'S THIRD SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED BY THE BIOMEDICAL STAFF PRIOR TO USE WITH NO ISSUE IDENTIFIED. THE PROCEDURE HAD BEEN IN PROGRESS ABOUT 1 HOUR WHEN THE SURGEON NOTICED THE RECTUM WAS VERY ATTACHED TO THE UTERUS. THE PROCEDURE CONVERTED TO OPEN SOLELY DUE TO PATIENT ANATOMY TO AVOID RISKS TO THE PATIENT. THE PATIENT TOLERATED THE CONVERTED PROCEDURE WITH NO COMPLICATIONS. THERE WAS NO SYSTEM/DEVICE MALFUNCTION PRIOR TO PROCEDURE CONVERSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204274 ↗
• MalfunctionDec 16, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT MESSAGE "INSERTION AXIS NOT FREE TO MOVE" APPEARED ON PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER POWER CYCLED THE SYSTEM, BUT THE MESSAGE PERSISTED. THE CUSTOMER STATED THAT THERE WAS NO OBSTACLE PREVENTING THE MOVEMENT OF THE INSERTION. THE TSE HAD THE CUSTOMER MOVE THE INSERTION AXIS TO THE TOP MANUALLY AND THEN PERFORM A HARD POWER CYCLE, WHICH CLEARED THE MESSAGE. HOWEVER, THE INSTRUMENT COULD NOT BE INSERTED INTO PSM 1. THE TSE EXPLAINED THAT THE INSERTION AXIS COULD HAVE PHYSICAL DAMAGE, AND PSM 1 COULD NOT BE USED IN THE PROCEDURE. THE SURGEON ELECTED TO CONTINUE THE PROCEDURE WITH THREE PSMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS POWERED ON WITHOUT ERROR. THE CUSTOMER DISABLED PSM 1 DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE REMAINING THREE PSMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998583 ↗
• InjuryNov 25, 2022No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY (RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ENDOSCOPIC CAMERA MANIPULATOR (ECM) MOVEMENT WAS STUCK ABOUT AN HOUR AFTER THE SURGERY STARTED. THE ECM ISSUE OCCURRED ON THE VERTICAL AXIS, WHICH COULD NOT BE MOVED UP AND DOWN. THE OTHER PATIENT SIDE MANIPULATORS (PSMS) WERE NORMAL. THE TSE REVIEWED THE ERROR LOGS BUT COULD NOT FIND ANY RELATED ERRORS. THE TSE HAD THE CUSTOMER PERFORM HARD POWER CYCLE AND REPLACE THE DRAPE, BUT THE ISSUE PERSISTED. THE SURGEON ELECTED TO CONVERT TO OPEN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CUSTOMER STATED THAT THERE WAS PATIENT INJURY BECAUSE THE INCISION SITE WAS EXTENDED AND PROLONGED PROCEDURE TIME. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866762 ↗