None 470067Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00886874120286), received between Jun 28, 2024 and Sep 25, 2026 — classified as 98 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (83 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 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902397 ↗
• MalfunctionSep 11, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725259 ↗
• MalfunctionSep 8, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, the 30 degree scope image orientation was flipped. The system was rebooted, which resolved the issue. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673300 ↗
• MalfunctionAug 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509186 ↗
• MalfunctionAug 11, 2026Detachment of Device or Device Component

  It was reported that during central processing with a 30-Degree Endoscope Plus, a piece on endoscope that attaches to the robot for use was separated from the viewing piece of the scope. There was no report of patient involvement or patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50216253 ↗
• MalfunctionAug 10, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, the customer experienced an inverted image while using a 30 degree Endoscope. The customer replaced the Endoscope and finished the procedure without further issue. The Technical Support Engineer (TSE) reviewed the system logs and found no associated errors. The TSE provided troubleshooting guidance to correct an inverted 30 degree Endoscope orientation by removing the scope from the arm, rotating the endoscope base until the correct orientation indicator (30 degree Up, 30 degree Down) appeared on the display, pressing the clutch button on the arm to cancel guided scope change, and reinstalling the endoscope. The customer planned to retest the suspect Endoscope and pursue return of the device if the issue persisted. The procedure was completed with no reported injury. ISI followed up with the initial reporter and obtained the following additional information: The Endoscope base was not damaged. The customer noted that the Endoscope was manually rotated prior to the issue, the Surgeon did not manually associate the right and left controls with the respective arms. The customer clarified that the Endoscope would not b

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194271 ↗
• MalfunctionAug 7, 2026Crack

  Patient problems: Insufficient Information

  MAUDE report 50178000 ↗
• MalfunctionAug 5, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138704 ↗
• MalfunctionJul 31, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted radical with lymphadenectomy prostatectomy surgical procedure, the customer informed Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) that image orientation of 30-Degree Endoscope was flipped. The customer power cycled the system, which resolved the issue. The procedure was completing as planned with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50103442 ↗
• MalfunctionJul 28, 2026Image Orientation Incorrect

  It was reported that prior to starting a da Vinci-assisted surgical procedure, Endoscope did not change orientation. The customer reported event has no report of patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50052216 ↗
• MalfunctionJul 28, 2026Image Orientation Incorrect

  It was reported that during central processing, the Endoscope was stuck in 30 down orientation. There was no report of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052213 ↗
• MalfunctionJul 28, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50051766 ↗
• MalfunctionJul 27, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047352 ↗
• MalfunctionJul 27, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047350 ↗
• MalfunctionJun 24, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CAMERA SLIPPED AND WAS UPSIDE DOWN IN THE SURGEON CONSOLE. THEY HAD TO UNDOCK THE ROBOT AND RE-DOCK TO RESET IT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610312 ↗
• MalfunctionJun 22, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ERROR CODE WHEN CHANGING THE ORIENTATION OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE ENDOSCOPE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580417 ↗
• MalfunctionJun 2, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT THE ENDOSCOPE IMAGE WAS FLIPPING. THE TSE EXPLAINED POTENTIAL CAUSES FOR THE ENDOSCOPE FLIPPING WHEN REINSTALLED ON THE ARM AFTER CLEANING. TSE REVIEWED THE SYSTEM LOGS AND OBSERVED THAT NO INSTRUMENTS WERE INSTALLED AT THAT TIME. THE TSE ADVISED THE CTA TO PERFORM A HARD POWER CYCLE AND TO MONITOR THE ISSUE FOR THE NEXT PROCEDURE. TSE ALSO PROVIDED GUIDANCE ON AN IN-PROCEDURE WORKAROUND BY CANCELLING THE GUIDE TOOL CHANGE (GTC) TO RESTORE PROPER IMAGE ORIENTATION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364492 ↗
• MalfunctionMay 29, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLOSTOMY CLOSURE SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN ISSUE WITH THE CAMERA HORIZON. THE CUSTOMER REPORTED THAT THE HORIZON WAS CORRECT ON THE VISION SIDE CART (VSC) AND MATCHED THE PHYSICAL ORIENTATION OF THE 30-DEGREE ENDOSCOPE, BUT THE HORIZON AT THE SURGEON SIDE CONSOLE (SSC) WAS INCORRECT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED RESEATING THE ENDOSCOPE AND REBOOTING THE SYSTEM IF THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE CSR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON THE SYSTEM ARMS, ONLY THE ENDOSCOPE POSITIONING WAS OFF. NO DAMAGE WAS OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE. THE ENDOSCOPE WAS UNPLUGGED AND PLUGGED BACK IN, AND A SYSTEM RESTART WAS PERFORMED; HOWEVER, THE ISSUE PERSISTED. THE CASE WAS COMPLETED WITH THE SAME ENDOSCOPE. CUSTOMER RESEATED AND CANCELLED GUIDED TOOL CHANGE TO FULLY RESET THE POSITION, BUT THE ERROR STILL OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333189 ↗
• MalfunctionMay 20, 2026Material Integrity Problem

  IT WAS REPORTED THAT 30-DEGREE ENDOSCOPE WAS FOUND BROKEN, AND A SYSTEM ERROR APPEARED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25235690 ↗
• MalfunctionMay 19, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CAMERA IMAGE FROM A 30-DEGREE ENDOSCOPE HAD AN INVERTED IMAGE, BUT AFTER A POWER CYCLE, THE IMAGE WAS CORRECTED. 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: THERE WAS NO UNCONTROLLED MOTION. THE EVENT DID NOT INVOLVE REVERSED CONTROLS. THE POWER WENT OUT AND WHEN IT CAME BACK, THE VIEW WAS BACKWARDS AND UPSIDE DOWN. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE. PRIOR TO THE EVENT THE ENDOSCOPE WAS MANUALLY ROTATED 180 DEGREES. THE TEAM IS UNSURE IF THE SURGEON MANUALLY ASSOCIATED THE RIGHT AND LEFT CONTROLS WITH THE RESPECTIVE ARMS FOR INTUITIVE MOTION. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO PHOTOS OR IMAGES WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220135 ↗
• MalfunctionMay 7, 2026Unexpected Shutdown

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE IMAGE ORIENTATION WAS FLIPPED. TECHNICAL SUPPORT GUIDED THE STAFF TO REMOVE THE ENDOSCOPE FROM THE ARM AND PRESS THE INSTRUMENT CLUTCH BUTTON TO CANCEL THE GUIDED TOOL CHANGE. THE STAFF THEN MANUALLY ROTATED THE ENDOSCOPE COLLAR AND SHAFT TO MATCH THE ORIENTATION SELECTED ON THE SYSTEM AND REINSTALLED THE ENDOSCOPE. THE USER CONFIRMED THAT THE IMAGE ORIENTATION WAS CORRECTED AND THE PROCEDURE CONTINUED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118632 ↗
• MalfunctionApr 24, 2026Crack

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990465 ↗
• MalfunctionApr 24, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT THE OPERATING ROOM MANAGER STATED THAT, PRIOR TO THE START OF THE CASE, THE IMAGE APPEARED FLIPPED. THE SURGEON THEN RESTARTED THE SYSTEM, AFTER WHICH THE IMAGE RETURNED TO NORMAL AND NO FURTHER TROUBLESHOOTING WAS REQUIRED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO SPECIFIC SCOPE OR INSTRUMENT IDENTIFIED, IT HAPPENED ON MULTIPLE CASES. THERE ARE NO PHOTOS FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982677 ↗
• MalfunctionApr 22, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, A CLINICAL SALES REPRESENTATIVE (CSR) CALLED TO REPORT A REFLECTION OF THE SURGICAL VIEW APPEARING ON THE 'CEILING' OF THE VIEWER WITH THE IMAGE BEING INVERSED. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED REPLACING THE SCOPE AND POWER CYCLING THE SYSTEM. NO FAULTS WERE REPORTED BY THE SYSTEM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960192 ↗
• MalfunctionApr 22, 2026Image Orientation Incorrect

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956921 ↗