N/A 72205155Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556736081), received between Feb 18, 2021 and Mar 25, 2021 — classified as 2 malfunctions.

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

• MalfunctionMar 25, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE SCOPE LENS WAS FOGGY. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED DISTAL LENS WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570186 ↗
• MalfunctionFeb 18, 2021Crack; Crack

  IT WAS REPORTED THAT THE DISTAL TIP OF THE SCOPE WAS SCRATCHED AND CRACKED. THIS WAS NOTICED AFTER THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342941 ↗