Brasseler USA 5027989RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887919872283), received between Feb 29, 2024 and Apr 3, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT SWALLOWED THE BUR.

  Patient problems: Foreign Body In Patient

  MAUDE report 19030094 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT WAS CUT INSIDE THE CHEEK.

  Patient problems: Laceration(s)

  MAUDE report 19030093 ↗
• InjuryFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT WAS CUT INSIDE THE CHEEK.

  Patient problems: Laceration(s)

  MAUDE report 18813114 ↗
• InjuryFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT SWALLOWED THE BUR.

  Patient problems: Foreign Body In Patient

  MAUDE report 18813113 ↗