NA 215419Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705004812), received between Mar 17, 2023 and Mar 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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.

• MalfunctionMar 30, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR TRAY DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DEVICE HAD EVIDENCE OF CONTAMINATION IN THE CANAL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644848 ↗
• MalfunctionMar 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 8 OF 11 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR TRAY DEVICE HAD CONTAMINATION IN AND ALONG ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566542 ↗