None 470056Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00886874116562), received between Nov 5, 2020 and Sep 28, 2026 — classified as 7 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (90 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 233 reports, in the reporter's own words as published by the FDA.

• OtherSep 28, 2026Material Fragmentation

  Patient problems: Foreign Body In Patient

  MAUDE report 50922362 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50905312 ↗
• MalfunctionSep 21, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848407 ↗
• MalfunctionSep 18, 2026Material Integrity Problem

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, the 0-deg Endoscope plus had a broken tip. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813691 ↗
• MalfunctionSep 15, 2026Output Problem

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, the Zero Degree Endoscope Plus was observed as needing repairThe procedure was completed as planned with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767493 ↗
• MalfunctionSep 11, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742741 ↗
• MalfunctionSep 1, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540762 ↗
• MalfunctionAug 24, 2026Optical Distortion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420282 ↗
• MalfunctionAug 12, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218052 ↗
• MalfunctionAug 11, 2026Material Integrity Problem

  It was reported that during a da Vinci-assisted surgical procedure, the 0-Degree Endoscope Plus failed self-test multiple times. Endoscope was washed and same error occurred. There is a dent on the distal end of the Scope. The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: There were no reports by staff or the surgeon that any fragments fell into a patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216075 ↗
• MalfunctionAug 10, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, the image displayed on the 0 Deg Endoscope Plus was upside down. The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the site to obtain additional information: No further details could be provided regarding the reported event, other than the team reporting the image was inverted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50199512 ↗
• MalfunctionAug 10, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted surgical procedure, a 30-degree Endoscope Plus was not responding to some commands. The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) contacted the customer and obtained the following information: The endoscope rotates on its own ¿upside down¿ without the surgeon at the console using any commands. The failure was related to poor responsiveness. The movement of the surgeon did not scale appropriately to the endoscope. The movement was lesser. The endoscope moved in the intended direction and the issue happened during the procedure. The procedure was completed robotically and there was no injury to the patient. The procedure was prolonged by 15 - 30 minutes. No fragments fell into the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195649 ↗
• MalfunctionAug 5, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50148692 ↗
• MalfunctionAug 5, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148614 ↗
• MalfunctionAug 3, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123507 ↗
• MalfunctionJun 30, 2026No Device Output

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER FOUND THE 0-DEGREE ENDOSCOPE PLUS WOULD NOT COMMUNICATE WITH SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25672807 ↗
• MalfunctionJun 22, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS HAD ROTATED WHEN IT WAS INSTALLED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). TECHNICAL SERVICE ENGINEER (TSE) REQUESTED FOR THE SITE TO REMOVE THE ENDOSCOPE FROM THE USM ARM, PRESS THE CLUTCH BUTTON TO CANCEL THE GUIDED TOOL CHANGE, AND THEN REINSTALL THE ENDOSCOPE. THE PROCEDURE WAS CONTINUING WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588384 ↗
• MalfunctionJun 22, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS WAS FOUND TO HAVE A DISTAL TIP BROKEN. THE CUSTOMER REPORTED EVENT HAD NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP WAS BROKEN OUTSIDE THE OR, NOT ANYWHERE NEAR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573030 ↗
• MalfunctionJun 3, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A 0-DEGREE ENDOSCOPE PLUS HAD AN ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MATERIALS DID NOT BECOME DETACHED INSIDE THE PATIENT, AS THE SCOPE WAS NOT USED ON THE PATIENT BECAUSE WHEN IT WAS PLUGGED IN, THEY GOT AN ERROR THAT THE RIGHT EYE WAS NOT WORKING. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369739 ↗
• MalfunctionMay 20, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE ORIENTATION ISSUE OCCURRED, CAUSING THE IMAGE TO FLIP TWICE. BEFORE CONTACTING TECHNICAL SUPPORT, THE ENDOSCOPE WAS REINSTALLED AND THE ISSUE WAS RESOLVED. SYSTEM LOGS WERE REVIEWED, BUT NO ERRORS OR FAILURES ASSOCIATED WITH THIS BEHAVIOR WERE FOUND. THE TROUBLESHOOTING PROCESS INCLUDED ADVISING STEPS FOR CORRECTING ORIENTATION AND PREVENTING RECURRENCE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233521 ↗
• MalfunctionMay 20, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE 0-DEGREE ENDOSCOPE PLUS WAS DEFECTIVE BUT NOT ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25226043 ↗
• MalfunctionMay 13, 2026Image Orientation Incorrect

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165174 ↗
• MalfunctionMay 11, 2026Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS HAD A CRACK LENS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO COMPLAINT BY THE STAFF THAT THE LENS WAS BROKEN OR INVOLVED IN A SURGICAL PROCEDURE. THIS WAS DISCOVERED OUTSIDE OF A SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 25143652 ↗
• MalfunctionMay 11, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE'S IMAGE WAS FLIPPED UPSIDE DOWN. THE CUSTOMER RESOLVED THE ISSUE BY HARD POWER CYCLING THE SYSTEM AND SWAPPING ENDOSCOPES. THE PROCEDURE WAS CONTINUED AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25137436 ↗
• MalfunctionMay 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ZERO DEGREE ENDOSCOPE PLUS DEFECT WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090332 ↗