M-access® HEDSTROEM FILE A16MA02101512Recalls & 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 J003A16MA021015121), received between Sep 27, 2023 and May 1, 2024 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Unintended Movement1
Patient problems
- Device Embedded In Tissue or Plaque1
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024Unintended Movement; Unintended Movement
IN THIS EVENT IT IS REPORTED THAT HEDSTROEM M-ACCESS 21MM 015 THAT WAS USED IN TREATMENT OF A PATIENT, PUNCTURED THE PATIENT IN THE MOUTH WHICH LED TO BLEEDING GUMS. TREATMENT WAS COMPLETED AND PATIENT HAD NO DISCOMFORT.
Patient problems: Needle Stick/Puncture
MAUDE report 19220771 ↗MalfunctionSep 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT HEDSTROEM M-ACCESS 21MM 015 REPORTEDLY APPEARS THAT THIS FILE HAD BROKEN IN THE ROOT CANAL DURING TREATMENT. PATIENT STILL FELT PAIN FOUR MONTHS AFTER THE ROOT CANAL TREATMENT. EXAMINATION REVEALED A 3 MM BROKEN FILE IN THE ROOT CANAL. ROOT CANAL WAS REPEATED ALONG WITH ANTI-INFLAMMATORY TREATMENT AND AFTER 15 DAYS THE PATIENT'S SYMPTOMS IMPROVED. TREATMENT ENDED.
Patient problems: Device Embedded In Tissue or Plaque; Pain
MAUDE report 17824390 ↗
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- EdgeTaper Platinum SETS125HTUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321US 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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