None 370892Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886874110201), received between Feb 19, 2022 and Jul 20, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Visual Prompts will not Clear; Optical Distortion; Visual Prompts will not Clear; Optical Distortion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359120 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THERE WAS A CRACK IN THE ENDOSCOPE LENS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883306 ↗
• MalfunctionOct 29, 2022Optical Distortion; Optical Distortion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696507 ↗
• MalfunctionOct 29, 2022Optical Distortion; Optical Distortion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 15695389 ↗
• MalfunctionAug 31, 2022Crack; Optical Discoloration; Crack; Optical Discoloration

  IT WAS REPORTED THAT PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDO SCOPE EXHIBITED A DARK AND PINKISH COLOR. THE PROCEDURE WAS COMPLETED USING A SPARE ENDOSCOPE WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UPS 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 15331804 ↗
• MalfunctionMar 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720183 ↗
• MalfunctionMar 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, BUT NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13702226 ↗
• MalfunctionMar 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD A FOGGING ISSUE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO RECORD OF PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOSCOPE. THE OPERATION WAS PROLONGED ABOUT 5 TO 10 MINUTES. THE REPORTER DID NOT HAVE THE REQUESTED PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696220 ↗
• MalfunctionMar 3, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE RIGHT LENS WAS NOT CLEAR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664658 ↗
• MalfunctionFeb 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP ENDOSCOPE WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587939 ↗
• MalfunctionFeb 19, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE HAD A FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 13-DEC-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13565344 ↗