NA 03.133.082Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982307521), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE 2 PIECES OF THE INSERTER OF THE FNS SYSTEM HAVE DAMAGED THREADS WHICH HAVE MADE THEM UNABLE TO ASSEMBLE AND THEY WERE DISCARDED BY STAFF AS THEY WERE UNUSEABLE. AS FOR THE CADDIES, THEY WERE PHYSICALLY DAMAGED BY A DROPS BEYOND USE, AND DISCARDED. AS FOR THE LID, THE LOCKING CLIP ON THE LID FELL OFF AND IT WILL NOT ATTACH TO TRAY SO IT WAS DISCARDED BY STAFF. AS FOR THE DEPTH GUAGE, THE METAL PIECE BROKE OFF SOMEWHERE IN THE STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485377 ↗