n.a. 26175BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551099001), received between Sep 2, 2025 and Sep 2, 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.

• MalfunctionSep 2, 2025Break; Material Separation; Break; Material Separation

  THE FOLLOWING WAS REPORTED: THE END OF THE INSTRUMENT HAS BROKEN OFF AND IS MISSING. THE CUSTOMER WAS MADE AWARE BUT WAS UNABLE TO CONFIRM WHERE THIS COULD HAVE HAPPENED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, DUE TO THE MISSING PART, THIS MALFUNCTION IS BEING REPORTED AS A PRECAUTIONARY MEASURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939386 ↗