daVinci Si 380690Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00886874110799), received between May 29, 2021 and Apr 21, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT ERROR 252 OCCURRED. THE PORTS WERE NOT IN PLACE WHEN THE ISSUE OCCURRED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) ADVISED THAT THE ERROR INDICATES THE SURGEON SIDE CONSOLE (SSC) WAS NOT CONNECTED WHEN THE SYSTEM WAS POWERED ON. THE TSE ADVISED THE BIOMED REPORTING THE ISSUE TO CONFERENCE WITH A TECHNICIAN TO PERFORM A HARD POWER CYCLE WITH A BLUE FIBER CABLE RESET, BUT THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CONTINUED LAPAROSCOPICALLY.

  Patient problems: Insufficient Information

  MAUDE report 24934429 ↗
• MalfunctionJun 17, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ENDOSCOPE WAS HAVING DISTORTED IMAGE IN LEFT EYE. SITE WAS HAVING ISSUE IN BOTH SCOPES. ERROR 48244 WAS SHOWING IN THE SYSTEM. TSE INFORMED SITE TO DO A HARD POWER CYCLE AND RESET THE LAMP MODULE. SITE WAS NOT ABLE TO RESET LAMP MODULE. LAMP MODULE HOURS WERE AT 559. AFTER SYSTEM HARD POWER CYCLE, ISSUE REMAINED THE SAME. SITE DID NOT HAVE A COMPATIBLE EXTERNAL LIGHT SOURCE. TSE INFORMED SITE THAT ISSUE CAN BE RELATED TO ILLUMINATOR OR CAMERA COMPONENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWER ON WITHOUT ERRORS. THE SYSTEM WAS RESTARTED TO RECOVER THE FAULT AND THE PROCEDURE WAS COMPLETED USING 2D VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22245206 ↗
• MalfunctionOct 23, 2024Energy Output Problem; Energy Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518788 ↗
• MalfunctionJul 23, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 48238 OCCURRED. THE CUSTOMER RECOVERED ERROR 48238, BUT ERROR 297 OCCURRED AFTER. THE CUSTOMER IDENTIFIED A DEFECTIVE ILLUMINATOR; THEREFORE, THE CUSTOMER POWER CYCLED THE SYSTEM, UNPLUGGED THE COMMUNICATION CABLE AND SWITCHED TO A THIRD-PARTY ILLUMINATOR TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812642 ↗
• MalfunctionJun 23, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FIELD SERVICE ENGINEER (FSE) CALLED THE CUSTOMER TO REPORT THAT ERROR 252 OCCURRED. THE SITE CONFIRMED THAT THEY HAD RESTARTED THE SYSTEM ONCE, BUT THE ERROR RETURNED. THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE SITE TO DO A FULL HARD POWER CYCLE, BUT THE ERROR PERSISTED. THE TSE INFORMED THE SITE TO RESET THE CABLE AT THE BACK OF THE CORE. THE SITE CALLED BACK AND CONFIRMED THAT RESEATING THE CABLES DID NOT RESOLVE THE ISSUE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591297 ↗
• InjuryJun 18, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THERE WAS A RECOVERABLE 45310 FAULT. THE INSTRUMENT HAD GRASPED THE TISSUE AND THE TSE SUGGESTED THAT THEY RELEASE THE TISSUE BY USING THE INSTRUMENT RELEASE KEY (IRK). THEY CONFIRMED TISSUE RELEASE BY USING THE IRK. THE TSE SUGGESTED THAT THEY REBOOT THE SYSTEM. IT WAS CONFIRMED ERROR 297 AFTER REBOOT. THE TSE REVIEWED LOGS AND TOLD THEM THAT THE ILLUMINATOR NEEDED TO BE REPLACED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO LOSS OF VISION AS THE LIGHT SOURCE ON THE CAMERA WAS NOT FUNCTIONAL. THERE WAS A SYSTEM MALFUNCTION INTRA-OPERATIVELY AND TROUBLESHOOTING WAS PERFORMED WITH THE DA VINCI SURGERY TECHNICAL ASSISTANCE TEAM (DVSTAT). THE PATIENT WAS NOT HARMED BECAUSE OF THE MALFUNCTION. THE LOSS OF LIGHT SOURCE FROM THE CAMERA RESULTED IN A MALFUNCTION WHICH LED TO LOSS OF VISION DURING THE PROCEDURE. THE SYSTEM WAS INSPECTED PRIOR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19562907 ↗
• MalfunctionMay 14, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE USER REPORTED A RED LED ON THE ILLUMINATOR. THE SITE'S BIOMEDICAL ENGINEER (CUSTOMER) SAID THEY HAD A RED LED ON THE ILLUMINATOR AND WERE NOT GETTING ANY LIGHT OUTPUT FROM THE LIGHT SOURCE. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER TO CHECK THE VALUE OF LIGHT HOURS FOR THE LAMP MODULE. THE BIOMEDICAL ENGINEER CONFIRMED 181 LAMP HOURS. THE CUSTOMER STATED THE HOSPITAL HAD CONNECTED AN EXTERNAL LIGHT SOURCE AND WAS PROCEEDING WITH SURGERY. THE SYSTEM WAS NOT CONNECTED TO THE ONSITE. THE ISI TSE INFORMED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM ONCE THE SURGERY WAS COMPLETED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER WAS UNABLE TO PROVIDE PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312278 ↗
• MalfunctionApr 22, 2024Poor Quality Image; Poor Quality Image

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159477 ↗
• MalfunctionDec 27, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED A RECOVERABLE FAULT 48245 DURING SYSTEM CHECK AND IDENTIFIED THE ILLUMINATOR WAS NOT WORKING. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CORRECT EVENT DATE WAS 2ND DECEMBER 2023. THE ISSUE HAPPENED BEFORE THE START OF THE PROCEDURE. AS SOON AS THEY SWITCHED ON THE ILLUMINATOR TO DO THE WHITE BALANCING, IT STOPPED WORKING. THE PATIENT WAS INDUCED, AND THE PROCEDURE WAS ABOUT TO START. THE PROCEDURE WAS CONVERTED AND DONE LAPAROSCOPICALLY. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PROCEDURE GOT CONVERTED WHEN THEY STARTED TO USE THE ENDOSCOPE AND IT STOPPED FUNCTIONING. THE PROCEDURE NAME WAS ROBOTIC HYSTERECTOMY. THE ISSUE HAS BEEN RESOLVED AND THE LAMP MODULE HAS BEEN REPLACED ALONG WITH THE ILLUMINATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406506 ↗
• MalfunctionDec 27, 2023Output Problem; Output Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406354 ↗
• MalfunctionJul 18, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ILLUMINATOR BRIGHTNESS LEVEL SUDDENLY DROPPED FROM 100 TO 0 AND AUTO RESTORED TO 100. THE CUSTOMER WAS SUGGESTED TO USE A THIRD-PARTY ILLUMINATOR TO CONTINUE WITH THE PROCEDURE. THE SYSTEM WAS NOT CONNECTED TO THE SYSTEM LOGS DURING THE SUPPORT CALL. THE CUSTOMER CONFIRMED NO ERROR MESSAGE ON THE SCREEN. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED TO CHECK CABLE CONNECTION BETWEEN THE CAMERA HEAD AND THE DUAL CAMERA CCU (DOCO). THE TSE ALSO SUGGESTED A SYSTEM RESTART AND CHECK AGAIN. THE PROCEDURE WAS COMPLETED 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 17347075 ↗
• MalfunctionJul 14, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 297 WAS NOTICED FOR THE ILLUMINATOR. THE PROCEDURE WAS COMPLETED 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 17329997 ↗
• MalfunctionMay 22, 2023No Device Output; Visual Prompts will not Clear; No Device Output; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SYSTEM DISPLAYED NON-RECOVERABLE ERROR 297. IT WAS NOTED THAT THE ILLUMINATOR LIGHT EMITTING DIODE (LED) INDICATOR WAS NOT ILLUMINATED. THE CUSTOMER THEN RECEIVED PHONE ASSISTANCE FROM AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). A REVIEW OF THE SITE'S SYSTEM LOGS CONFIRMED THE OCCURRENCE OF THE NON-RECOVERABLE ERROR 297 AND RECOVERABLE ERROR 48238. THE CUSTOMER WAS INSTRUCTED TO DISCONNECT THE COMMUNICATION CABLE BETWEEN THE ILLUMINATOR AND THE DUAL CAMERA CCU (DOCO) AND PERFORM A POWER-CYCLE. ONCE THE SYSTEM POWERED BACK ON, THE CUSTOMER RECOVERED FROM THE ERROR FAULT. FOLLOWING THIS, AN EXTERNAL LAPAROSCOPIC ILLUMINATOR WAS CONNECTED TO CONTINUE THE PROCEDURE. NO FURTHER ISSUE WAS OBSERVED. 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 16971837 ↗
• MalfunctionMay 18, 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 16957621 ↗
• MalfunctionApr 12, 2023Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL ESOPHAGECTOMY TRANSTHORACIC WITH CHEST ANASTOMOSIS PROCEDURE, THE CUSTOMER WAS FACING AN ISSUE WITH THE VESSEL SEALER. THE CUSTOMER STATED THAT THERE WAS NO EFFECT WHEN THE PEDAL WAS PRESSED. THE CUSTOMER STATED THAT THEY TRIED A SECOND VESSEL SEALER BEFORE CALLING INTO TECHNICAL SUPPORT WITHOUT ANY SUCCESS. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED HER TO CHECK THE INSTRUMENT CONTROL BOX (ICB) MODULE AND IT WAS ON. THE TSE THEN ASKED THE CUSTOMER TO REBOOT THE GENERATOR, TRY THE VESSEL SEALER ON ANOTHER ARM WITH NO SUCCESS. THE TSE CONFIRMED WITH THE CUSTOMER THAT THERE WAS A SOUND WHEN THE PEDAL WAS PRESSED. THE TSE ASKED THE CUSTOMER TO REMOVE ALL INSTRUMENTS AND RESTART THE SYSTEM AND POWER CYCLE THE VISION SIDE CART (VSC) BREAKER BUT THERE WAS NO CHANGE. THE TSE ASKED THE CUSTOMER TO DISCONNECT THE ELECTRIC SCALPEL CONNECTED TO THE PERSONALITY MODULE ENERGY DEVICE (PMED) AT THE BACK SIDE OF THE VSC WITH NO CHANGE. THE TSE ASKED CUSTOMER TO USE A THIRD VESSEL SEALER BUT THERE WAS NO CHANGE. THE SURGICAL STAFF DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THEY WOULD LIKE ASSISTANCE FROM A FIELD SERVICE ENGINEER (FSE). THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725102 ↗
• MalfunctionMar 21, 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 16580405 ↗
• MalfunctionMar 4, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE LIGHT SOURCE WAS NOT GETTING TURN ON THROUGH CAMERA HEAD/LIGHT SOURCE ONCE THEY TURN OFF IT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND CONFIRMED AN ERROR 48245 ON THE ILLUMINATOR. THE CUSTOMER CONFIRMED THAT THE LAMP MODULE WAS REPLACED FOR THE SAME ISSUE PREVIOUSLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THERE WERE NO ERROR ON INITIAL BOOTUP. THE CUSTOMER RECOVERED THE ERROR TO PROCEED. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483450 ↗
• MalfunctionNov 6, 2022Visual 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 15741505 ↗
• MalfunctionNov 1, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD AN ADVISORY MESSAGE STATING THAT "THE ILLUMINATOR LAMP MODULE WAS NOT FOUND". AN ILLUMINATOR WAS WORKING FINE. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THE CUSTOMER TO POWER OFF AND POWER ON BACK THE ILLUMINATOR BUT THE ISSUE STILL PERSISTED. THE CUSTOMER POWER CYCLED THE SYSTEM BUT THE ISSUE CONTINUED. THE TSE ASKED THE CUSTOMER TO RESEAT THE LAMP MODULE. THE CUSTOMER INFORMED THAT THE LIGHT GUIDE CABLE WAS BURNT. THE TSE INFORMED THE CUSTOMER TO USE BACKUP CAMERA HEAD FROM ANOTHER SYSTEM, IF REQUIRED USE THIRD PARTY ILLUMINATOR. THE TSE REVIEWED THE SYSTEM LOGS AND FOUND ERRORS 48247, 48246, 45311 AND 45310 IN THE LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED ISSUE OCCURRED DURING PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE ILLUMINATOR INITIALLY POWERED ON WITH SYSTEM ADVISORY MESSAGE "LAMP MODULE NOT FOUND". BUT THE ILLUMINATION WAS PRESENT. THE CUSTOMER REPLACED THE LAMP MODULE AND USED A BACKUP CAMERA HEAD. THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712734 ↗
• MalfunctionOct 27, 2022Defective Component; Defective Component

  AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS INFORMED THAT THE SYSTEM DID NOT RECOGNIZE THE LAMP MODULE. IT WAS REPORTED THAT THE NURSE RESEATED THE LAMP MODULE AND CLEANED THE CONTACT SURFACES ON THE ILLUMINATOR. THE FSE NOTED THAT AFTER THE NURSE TRIED A NEW LAMP MODULE, THE LIGHT WAS PERFECT. THE FSE ALSO NOTED THAT A REPLACEMENT ILLUMINATOR WAS NEEDED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CLARIFIED THAT AFTER REPLACING THE LAMP, THE SAME INDICATOR REOCCURRED. THE ISSUE OCCURRED DURING THE PROCEDURE, AND IT COULD BE COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686744 ↗
• MalfunctionOct 27, 2022Optical Discoloration; Optical Discoloration

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686681 ↗
• MalfunctionApr 8, 2022Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY - DISTAL SURGICAL PROCEDURE, THE VESSEL SEALER (VS) INSTRUMENT WAS NOT FIRING WHEN SURGEON SIDE CONSOLE (SSC) PEDAL WAS PUSHED. THE CUSTOMER POWER CYCLED THE SYSTEM. HOWEVER; THE ISSUE PERSISTED. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES WITH NO INJURY REPORTED. THE CUSTOMER STATED ANOTHER VS INSTRUMENT WAS WORKING AS EXPECTED DURING THE PRIOR PROCEDURE ON THE SAME DAY. A TECHNICAL SUPPORT ENGINEER ADVISED THE CUSTOMER TO TEST THE ELECTRO SURGICAL UNIT (ESU) WITH THE VS EMULATOR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND CLINICAL SALES REPRESENTATIVE OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VS INSTRUMENT (PN# 410322-05 / LOT# M10211207-606) NEVER WORKED DURING THE PROCEDURE. THE CUSTOMER DID NOT HAVE A 3RD PARTY BACKUP ESU AND REPORTEDLY THE VS INSTRUMENT WAS CRUCIAL FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058267 ↗
• MalfunctionMay 29, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO STARTING (POST-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS NO LEFT EYE ON THE CAMERA AND ERROR 45311 OCCURRED. PRIOR TO CALLING TECHNICAL SUPPORT, THE NURSE POWER CYCLED THE SYSTEM. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE LOSS OF LEFT EYE VISION DUE TO ERROR 45311. THE TSE GUIDED THE CALLER TO SHUT DOWN THE SYSTEM AND RESEAT THE CAMERA CABLE. THEN, THE TSE GUIDED THE CALLER TO POWER CYCLE THE ENDOSCOPE CONTROLLER (EC), DUAL CONTROLLER (DOCO), VISION SIDE CART (VSC), AND RESEAT THE CAMERA CABLES. AFTER STARTUP, THE USER RECOVERED VISION IN BOTH EYES. POST PORT PLACEMENT, ERROR 45311 REOCCURRED. THE NURSE REPLACED THE CAMERA AND CAMERA CABLE; HOWEVER, THE ERROR DID NOT RESOLVE. THE TSE REVIEWED THE LIVE LOGS AND SAW ERRORS 45311 AND 45314 POINTING TO THE CAMERA VIDEO CHAIN. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905540 ↗