None 371938Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886874110423), received between Feb 28, 2022 and May 27, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionMay 27, 2023Material Separation; Material Separation

  IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE, THE ENDOSCOPE HAD ONE BLURRY EYE AND WOULD NOT FOCUS. THE SITE PROCEEDED WITH THE CASE AS PLANNED USING A BACK-UP ENDOSCOPE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015677 ↗
• MalfunctionMay 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ENDOSCOPE WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015672 ↗
• MalfunctionMay 27, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD TO IMAGE DISPLAYED IN RIGHT EYE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015671 ↗
• MalfunctionMay 21, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE ENDOSCOPE WAS ACCIDENTALLY AUTOCLAVED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971232 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ENDOSCOPE INSTRUMENT WAS BLURRY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883623 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ENDOSCOPE HAD DARK IMAGE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WAS AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883611 ↗
• MalfunctionOct 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE SI ENDOSCOPE HAD ONE EYE THAT WAS BLURRY. A SPARE SCOPE WAS USED. 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 PATIENT INVOLVEMENT AS THE ISSUE WAS IDENTIFIED BEFORE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612710 ↗
• MalfunctionOct 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE 0 DEGREE ENDOSCOPE HAD POOR VISION QUALITY. THERE WAS NO REPORT OF PATIENT INJURY. THE DA VINCI SI ENDOSCOPE IS INTENDED TO PROVIDE STEREOSCOPIC VISUALIZATION OF TISSUE AND INSTRUMENTS WHEN PERFORMING PROCEDURES WITH THE DA VINCI SYSTEM. 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 15612709 ↗
• MalfunctionMar 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED DURING CENTRAL PROCESSING AND CLEANING, THE ENDOSCOPE HAD A CLOUDY IMAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SITE INFORMED THAT THERE WAS NO REPORT OF FRAGMENT FALLING INTO THE PATIENT AND NO REPORT OF POST-OPERATIVE COMPLICATIONS WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713670 ↗
• 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 0-DEGREE ENDOSCOPE WAS OBSERVED TO HAVE FOGGING ISSUES. A SPARE ENDOSCOPE OF THE SAME KIND WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH A BACK-UP ENDOSCOPE. SITE WAS NOT ABLE TO PROVIDE PATIENT INFORMATION DUE TO HIPPA REGULATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691137 ↗
• MalfunctionFeb 28, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13616162 ↗