Brasseler USA 5003979M0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887919445500), received between Mar 28, 2022 and Mar 28, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 28, 2022Break

  DURING OPEN HEART SURGERY, THE SURGEON OPENED THE CHEST & NOTICED ONE OF THE SIDE ARMS FROM THE SAW BLADE BROKE OFF. A CHEST X-RAY WAS TAKEN. THE MISSING PIECE WAS NOT VISUALIZED ON THE X-RAY. NO FOLLOW-UP TREATMENT WAS NEEDED. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13932906 ↗