M-access® HEDSTROEM FILE A16MA02501512Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J003A16MA025015121), received between Apr 3, 2024 and Dec 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Laceration(s)2
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A HEDSTROEM M-ACCESS 25MM 015 FILE BROKE DURING USE. THE BROKEN PART OF THE FILE FLEW OUT AND INJURED THE ORAL SOFT TISSUE OF THE PATIENT. THE PATIENT IMMEDIATELY EXPERIENCED SEVERE PAIN AT THE INJURY SITE. THE PATIENT WAS URGENTLY INSTRUCTED NOT TO SWALLOW, SO THEY WOULD NOT SWALLOW THE BROKEN PART OF THE FILE. UPON EXAMINATION A WOUND WAS FOUND ON THE LEFT ORAL MUCOSA THAT MEASURED APPROXIMATELY 0.2 CM × 0.1 CM, WITH PART OF A METAL FRAGMENT EMBEDDED IN THE WOUND. THE FRAGMENT WAS IMMEDIATELY REMOVED, AND GAUZE WAS APPLIED FOR HEMOSTASIS. THE PATIENT WAS PRESCRIBED ORAL ROXITHROMYCIN DISPERSIBLE TABLETS AS AN ANTIBIOTIC. AFTER 2 FOLLOW-UP VISITS, THERE WAS NO UNEXPECTED COMPLICATIONS.
Patient problems: Laceration(s); Pain
MAUDE report 23906709 ↗MalfunctionApr 3, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT HEDSTROEM M-ACCESS 25MM 015 BROKE DURING USE. PATIENT'S GUM WAS SCRATCHED IN THIS EVENT.
Patient problems: Laceration(s)
MAUDE report 19031147 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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