None 370891Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874110195), received between Feb 25, 2022 and May 31, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE 30 DEGREES ENDOSCOPE HAD A MISSING LENS AT THE TIP. ONE OF THE LENSES WAS DENTED. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER DID NOT OBTAIN INFORMATION TO DENY FALLEN FRAGMENT INTO THE PATIENT'S BODY. THE NURSE FOUND THE LENS DAMAGE JUST BEFORE INSERTING THE ENDOSCOPE INTO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE CUSTOMER WILL BE RETURNING THE DAMAGED ENDOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14556406 ↗
• MalfunctionMar 9, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE WAS FOUND TO HAVE RECOGNITION FAILURE. THE SAME ENDOSCOPE WAS ABLE TO BE 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 ISSUE WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE, SO THE PATIENT WAS NOT INVOLVED. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13703657 ↗
• MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 13697238 ↗
• 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 13602541 ↗
• 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 13602377 ↗