MITEK 242023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705028993), received between Dec 14, 2022 and Dec 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE HD EPSCP,4.0,70,270,MITEK DEVICE HAD A POOR IMAGE QUALITY. THE EVENT WAS NOT RELATED TO SURGERY. IT WAS REPORTED THAT THE DEVICE WAS NOT INTENDED FOR HUMAN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819620 ↗
• MalfunctionDec 14, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 270MM (MITEK LOCK) DEVICE WAS CLOUDY AND ITS VIEW WAS OFF CENTER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980757 ↗