NA 242107Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705031962), received between Aug 5, 2025 and Feb 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Display or Visual Feedback Problem

  POOR IMAGE QUALITY. IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE HD EPSCP,2.7,30,75,MITEK SCOPE IMAGE WAS BLURRING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WILL BE REPAIRED IN CHINA CUSTOMER TECHNICAL SERVICE CENTER, NOT RETURN TO OPCO. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319056 ↗
• MalfunctionJan 21, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD EPSCP,2.7,30,75,MITEK DEVICE WAS CLOUDY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132484 ↗
• MalfunctionAug 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD EPSCP,2.7,30,75,MITEK SCOPE DEVICE WAS DISPLAYING A CLOUDY IMAGE. IT WAS REPORTED THAT THE DEVICE WAS SWAPPED FOR ANOTHER DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717348 ↗