EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm DM0008FAA (UDI 07898959543623)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07898959543623), received between Aug 21, 2024 and Dec 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Remains Activated” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOPS DURING CRANIOTOMY PROCEDURE AND CAUSED INJURY. THE SURGEON REACTED IN TIME AND PREVENTED MORE SERIOUS DAMAGE. THE PATIENT IS IN PERFECT HEALTH, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. ON ADDITIONAL FOLLOW UP THERE WAS A DELAY OF PROCEDURE UP TO TWO HOURS TO PERFORM A RECONSTRUCTIVE PROCEDURE OF THE DURA MATER.

  Patient problems: Dural Tear; Perforation

  MAUDE report 23921084 ↗
• InjuryAug 21, 2024Device Remains Activated; No Apparent Adverse Event; Device Remains Activated; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CLUTCH MECHANISM DIDN¿T WORK, AND DRILL SCRATCHED THE DURA. IT WAS REPORTED THAT THERE WERE NO ADDITIONAL I NTERVENTIONS PERFORMED. ON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Spinal Cord Injury

  MAUDE report 20009210 ↗