None 470026Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00886874112205), received between Jul 31, 2020 and Apr 8, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (10 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THAT THE NIR HANDHELD CAMERA WAS BEING USED AS A LIGHT SOURCE. AFTER USE, THE CAMERA WAS LAID ON DRAPING AND A HOLE WAS BURNED THROUGH IT. THE PROCEDURE WAS COMPLETED, WITH NO REPORTS OF PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: IT IS BELIEVED THAT THE ISSUE OCCURRED DURING A ROBO TAH PROCEDURE. THERE WAS NO HARM TO THE PATIENT AT ALL. THE CUSTOMER PLACED A COVERING OVER THE HOLE IN THE DRAPE AND PERFORMED THE REST OF THE CASE WITHOUT INCIDENT. THE METAL PART OF THE LIGHT CORD WAS STILL VERY HOT AT THE END OF THE PROCEDURE, EVEN AFTER IT WAS TURNED OFF AND DISCONNECTED FROM THE LAPAROSCOPIC SCOPE.

  Patient problems: Insufficient Information

  MAUDE report 24816094 ↗
• MalfunctionNov 12, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS HAD A BROKEN LENS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529869 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SIMPLE TRANSVESICAL PROSTATECTOMY SURGICAL PROCEDURE; THE 8 MM 0-DEGREE ENDOSCOPE INSTRUMENT HAD MISSING SCREWS. THE ENDOSCOPE'S ROTATING GEARS TO BASE OF CAMERA HEAD MISSING. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748225 ↗
• MalfunctionJun 6, 2025Failure to Calibrate; Failure to Calibrate

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22160240 ↗
• MalfunctionSep 27, 2024Image Orientation Incorrect; Image Orientation Incorrect

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327377 ↗
• MalfunctionSep 14, 2024Image Orientation Incorrect; Image Orientation Incorrect

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20219341 ↗
• MalfunctionMay 16, 2024Unintended Movement; Unintended Movement

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335122 ↗
• MalfunctionJan 31, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611779 ↗
• MalfunctionJan 29, 2024No Display/Image; Unintended System Motion; No Display/Image; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE INSTRUMENT HAD A FUZZY VIEW, AND THE EYES ON THE SURGEON SIDE CONSOLE (SSC) HAD TWO SEPARATE IMAGES. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL TASK BEING PERFORMED WAS A DA VINCI LAPAROSCOPY, BILATERAL SALPINGECTOMY, EXCISION, AND ENDOMETRIOSIS, CYSTOSCOPY. THE IMAGE WAS FUZZY AND IN SURGEON SIDE CONSOLE (SSC) 2 THERE WERE TWO SEPARATE IMAGES. THE ENDOSCOPE DID MOVE FREELY WITH UNCONTROLLED MOTIONS. THE EVENT DID NOT INVOLVE A REVERSED CONTROL OF SYSTEM ARMS. IT WAS A 0-DEGREE ENDOSCOPE. THE SURGEON DID CONFIRM THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. THERE WAS AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA THE USER INTERFACE. THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE ARE STILL ENGAGED/IN SYNC/ATTACHED. THERE WAS DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE SUCH AS A MISSING SCREW(S) OR COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603327 ↗
• MalfunctionNov 20, 2023Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE HORIZON WAS NOT LEVELED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177404 ↗
• MalfunctionNov 9, 2023Image Orientation Incorrect; Unintended System Motion; Image Orientation Incorrect; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104115 ↗
• MalfunctionOct 16, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE IMAGE WAS UPSIDE DOWN. THE SITE REMOVED THE ENDOSCOPE AND ERASED THE GUIDED TOOL CHANGE FEATURE. THE ENDOSCOPE WAS REINSTALLED, AND THE IMAGE WAS NOW APPEARING NORMALLY. THE SURGEON IS PROCEEDING WITH THE CASE. THE SYSTEM LOGS WERE REVIEWED WITH NO ISSUES FOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEON CONFIRMED THIS HAPPENED IN THE MIDDLE OF THE CASE. SURGEON DOESN'T RECALL THE EXACT PORTION BUT DOES RECALL THAT BOTH THE 30-DEGREE SCOPE AND THE 0-DEGREE HAD THIS ISSUE. THE ENDOSCOPES WERE INSERTED PROPERLY WITH PROPER ORIENTATION. THE IMAGE ORIENTATION APPEARED CORRECT IN THE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946667 ↗
• InjuryOct 3, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER LOST VIDEO OUTPUT WITH A BLUE SCREEN AND HAD A WARNING MESSAGE THAT THE ENDOSCOPE TIP MIGHT BE HOT, AVOID CONTACT WITH PATIENT TISSUE. PRIOR TO CALLING, THE CUSTOMER HAD CONVERTED TO OPEN SURGERY SINCE THE SURGEON WAS IN THE ISCHEMIA AND COULD NOT WAIT FOR TROUBLESHOOTING. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND FOUND SEVERAL 48221 ERRORS, POINTING TO A COMMUNICATION PROBLEM BETWEEN THE 0-DEGREE ENDOSCOPE AND THE ENDOSCOPE CONTROLLER (EC). THE TSE ALSO CONFIRMED ERRORS 48216, 48218 AND 45310. THE CUSTOMER DID NOT PERFORM ANY TROUBLESHOOTING BEFORE CONTACTING THE TSE. THE TSE HAD THE CUSTOMER UNPLUG AND RE-PLUG THE 0-DEGREE ENDOSCOPE AND RESOLVED THE ISSUE. THE CUSTOMER WAS CONCERNED ABOUT USING THE SYSTEM AGAIN. THE TSE HAD THE CUSTOMER CHECK FOR DEBRIS AND DAMAGE ON THE EC CONNECTOR. NO DEBRIS OR DAMAGE WAS FOUND. THE PROCEDURE WAS CONVERTED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859836 ↗
• MalfunctionAug 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE 3D VIEWER LOST VIDEO. THE ENDOSCOPE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT 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 17463258 ↗
• MalfunctionJul 27, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE SUDDENLY STARTED MOVING IN THE OPPOSITE DIRECTION IN REFERENCE TO THE MASTER TOOL MANIPULATOR MOVEMENT. THE CUSTOMER STATED THAT THE SYSTEM HAD BEEN HARD POWER CYCLED, AND INSTRUMENTS WERE RESEATED, BUT ISSUE PERSISTED. ASSIGNMENT OF INSTRUMENTS WERE CORRECT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CUSTOMER TO REPLACE THE ENDOSCOPE. AFTER DOING SO, THE MOVEMENT RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410567 ↗
• InjuryJul 26, 2023Misfocusing; Misfocusing

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398901 ↗
• InjuryJul 26, 2023Misfocusing; Misfocusing

  IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER DOCKING DUE TO THE LEFT EYE ON A 0-DEGREE ENDOSCOPE BEING BLURRY. THE CUSTOMER TRIED TO TROUBLESHOOT BY REPLACING THE ENDOSCOPE, BUT THE IMAGE WAS STILL BLURRED. THE TSE HAD THE CUSTOMER POWER CYCLE AND HARD CYCLE THE VISION SIDE CART (VSC) BUT THE IMAGE WAS STILL NOT COMING UP NORMALLY. THE TSE HAD THE CUSTOMER VERIFY THE IMAGE WAS BAD ON THE VSC AS WELL AS ON THE SURGEON SIDE CART (SSC). THE SURGEON OPTED TO CANCEL THE CASE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS FINE. THERE WERE NO COMPLICATIONS OR PATIENT INJURY POST-ANESTHESIA. THEY JUST HAD TO WAKE UP THE PATIENT AS THERE WAS NO SCOPE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398762 ↗
• MalfunctionJul 14, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT, THE ENDOSCOPE DID NOT RESPOND TO THE SURGEONS' CONTROLS; AND THE HORIZON WAS NOT CORRECT AND WOULD NOT CORRECT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE A FOLLOW-UP ATTEMPT 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 17330140 ↗
• MalfunctionJul 13, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE HAD AN INVERTED IMAGE. NO FURTHER INFORMATION WAS PROVIDED. THE USER CONTINUED THE PROCEDURE WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322119 ↗
• MalfunctionMay 27, 2023Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, ONE EYE OF THE 8MM ENDOSCOPE WAS COMPLETELY BLURRY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WHILE WAITING FOR ANOTHER ENDOSCOPE TO BE PROCESSED FOR USAGE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO OTHER 0-DEGREE SCOPE AVAILABLE AT THE TIME OF THE EVENT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015863 ↗
• MalfunctionMay 27, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE SURGEON OPTED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC PROCEDURE, AS THEY HAD ENCOUNTERED A FLASHING IMAGE WITH THE 8MM ENDOSCOPE. TROUBLESHOOTING WAS NOT ATTEMPTED. WHEN THE SURGEON TRIED TO SEE THE IMAGE WITHOUT USE OF THE ENDOSCOPE, THEY OBSERVED THE IMAGE HAD SOME SNOW/STATIC ON THE VISION SIDE CART (VSC) TOUCH SCREEN. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED HARD-CYCLING THE VSC WHEN POSSIBLE. A REVIEW OF THE SYSTEM LOGS PERFORMED BY THE TSE REPORTED 45314 FAULTS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY TO THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SITE'S NURSE CONFIRMED THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING LAPAROSCOPY, WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015859 ↗
• MalfunctionMay 27, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-MALIGNANT SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A REPEATED 45310 RECOVERABLE ERROR. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THEM SYSTEM LOGS AND NOTED COMMUNICATION ERRORS POINTING TO THE 8MM ENDOSCOPE. THE CUSTOMER RESEATED THE ENDOSCOPE TO THE ENDOSCOPE CONTROLLER (EC) FIVE TIMES, HOWEVER THE ERROR PERSISTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE LAPAROSCOPIC PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015858 ↗
• MalfunctionMay 27, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, INTERFERENCE WAS EXPERIENCED WHEN FIRING THE CAUTERY INSTRUMENT. THE CUSTOMER STARTED TO COVERT THE CASE TO LAPAROSCOPIC SURGERY BEFORE CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE CUSTOMER DECLINED TO TROUBLESHOOT WITH AN ISI TECHNICAL SUPPORT ENGINEER (TSE). PRIOR TO THE CALL, THE CUSTOMER STATED THE MONOPOLAR INSTRUMENT CORD WAS REPLACED AND THEY MOVED THE ERBE POWER CORDS FROM ONE OUTLET TO ANOTHER, HOWEVER THE ISSUE PERSISTED. TSE REVIEWED LIVE SYSTEM LOGS AND OBSERVED VIDEO LOSS ERRORS IN THE LOGS, POINTING TO THE ENDOSCOPE. TSE STATED THAT THE ISSUE IS LIKELY SPECIFIC TO THE ENDOSCOPE AND RECOMMENDED DISCONTINUING USE. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015857 ↗
• MalfunctionMay 27, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THERE WAS MECHANICAL DAMAGE ON ONE OF THE LENSES AND THE OVERALL OPTICS WERE SEVERELY LIMITED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015679 ↗
• MalfunctionMay 25, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, THE ENDOSCOPE HAD AN IMAGE ORIENTATION ISSUE. 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 17003630 ↗