Brasseler USA 5027608U0Recalls & reported problems
Peter Brasseler Holdings, LLC · FORZA M5 1:5 ATTACHMENT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887919851400), received between Jan 8, 2024 and Jul 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Overheating of Device” (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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device1
- Temperature Problem1
Patient problems
- Burn(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2025Overheating of Device; Overheating of Device
ON JUNE 9, 2025, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR (B)(4) ABOUT AN ADVERSE EVENT IN WHICH AN NSK HANDPIECE HAD BEEN INVOLVED. DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON MAY 13, 2025. THE DENTIST WAS PERFORMING A CROWN PREPARATION PROCEDURE ON A PATIENT USING THE FORZA M5 HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE DENTIST NOTICED SMALL BURN APPROXIMATELY THE SIZE OF A PENCIL ERASER ON THE INSIDE MUCOSA OF THE PATIENT'S CHEEK. THE HEAD OF THE HANDPIECE HAD HEATED UP. THE DENTIST APPLIED AN ANTIBIOTIC OINTMENT TO THE BURN. THE PATIENT WAS INSTRUCTED TO RINSE WITH CHLOROHEXIDINE RINSE.
Patient problems: Burn(s)
MAUDE report 22368264 ↗InjuryJan 8, 2024Temperature Problem; Temperature Problem
THE CUSTOMER WAS USING THE HANDPIECE DURING A CAVITY PREPARATION. THE HANDPIECE WAS SPINNING AND THE DOCTOR SAID IT WAS LOUDER THAN NORMAL. THE BACKCAP OF THE HANDPIECE GOT HOT BUT THE DOCTOR DIDN'T NOTICE. HE HAD IT PRESSED UP AGAINST THE PATIENT'S LIP. THE PATIENT WAS NUMB AND BY THE TIME HE WAS DONE THE INSIDE OF THE LIP TURNED WHITE WITH A SLIGHT BURN. LIP BURN CREAM WAS APPLIED.
Patient problems: Burn(s)
MAUDE report 18469065 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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