M-access® K-FILE A12MA02500612Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
All models of M-access K-FILE (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J003A12MA025006121), received between Jul 17, 2024 and Jun 11, 2025 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- Hemorrhage/Blood Loss/Bleeding1
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 006 THE PLASTIC HANDLE OF THE FILE BROKE DURING USE THAT CAUSED THE DOCTOR TO LOSE CONTROL OF THE FILE AND BE UNSTEADY. THE PATIENT WAS STABBED IN THE GINGIVAL MUCOSA AND BLED DUE TO THIS BREAKAGE OF THE FILE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture
MAUDE report 22188661 ↗MalfunctionJul 17, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 006 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19762939 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- Brasseler USA 5026670U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page