NA 219635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705024308), received between Feb 15, 2023 and Feb 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 19 OF 28 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE LOW PROFILE REAMER, 11.5MM DEVICE HAD CONTAMINATION INSIDE ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. IT WAS REPORTED THAT THE DEVICE WAS PURCHASED ON (B)(6) 2022; AND HAS NEVER BEEN USED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SHELVED AND STORED IN CONTROLLED ENVIRONMENT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382158 ↗