None 370890Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886874110188), received between Feb 20, 2022 and Mar 24, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE 0 DEGREE ENDOSCOPE WAS RETURNED AS A TRADE-IN. THERE WAS NO REPORTED FAILURE BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612845 ↗
• MalfunctionMar 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A FOGGING ISSUE WITH THE 0 DEGREE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. PER SUBSEQUENT FOLLOW-UP, THE CUSTOMER CONFIRMED A SPARE ENDOSCOPE WAS USED TO PROCEED WITH THE CASE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715007 ↗
• MalfunctionMar 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, BLURRY VISION IN ONE EYE ON THE 0° ENDOSCOPE OCCURRED. A BACKUP ENDOSCOPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE PROBLEM WITH ENDOSCOPE WAS DETECTED IN THE STAGES OF PREPARATION FOR SURGERY AND SCOPE CALIBRATION. A BACKUP ENDOSCOPE WAS UNPACKED IMMEDIATELY AND USED FROM BEGINNING OF SURGERY. THE CUSTOMER REPORTED THERE IS NO CONCERN THAT THE MISSING FRAGMENT HAS REACHED THE PATIENT. THE CUSTOMER STATED THE DAMAGE OCCURRED DURING TRANSFER, OR CLEANING IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13706898 ↗
• MalfunctionFeb 25, 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 13602682 ↗
• MalfunctionFeb 24, 2022Defective Device; Defective Device

  THE ENDOSCOPE WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) WITH NO ALLEGATION OF A PRODUCT COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596510 ↗
• MalfunctionFeb 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PRIOR TO STARTING, PRE-ANESTHESIA, A DA VINCI ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE WAS NOT RECOGNIZED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13575940 ↗
• MalfunctionFeb 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0° ENDOSCOPE WAS FOUND TO HAVE DARK IMAGE IN RIGHT EYE. A BACKUP ENDOSCOPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE DA VINCI SI ENDOSCOPE IS INTENDED TO PROVIDE STEREOSCOPIC VISUALIZATION OF TISSUE AND INSTRUMENTS WHEN PERFORMING PROCEDURES WITH THE DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) HAS PERFORMED FOLLOW-UP TO REQUEST ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13565425 ↗