EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm DM0008FAA (UDI 07898959543050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07898959543050), received between Oct 27, 2017 and Aug 20, 2018 — 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.

• InjuryAug 20, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING BOREHOLE TRIPANNING, THE DRILL DID NOT STOP AUTOMATICALLY. IT WAS REPORTED THAT THERE WAS INJURY TO THE PATIENT DURA.

  Patient problems: Perforation

  MAUDE report 7799126 ↗
• InjuryOct 27, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP AND CAUSED THE DURA TO BECOME BROKEN. IT WAS REPORTED THAT THERE WAS NO OTHER PATIENT IMPACT. ON FOLLOW UP IT WAS REPORTED BY THE SURGEON THAT THE PERFORATOR DID NOT STOP. WHEN HE SAW THIS, HE WITHDREW THE DRILL AND THERE WAS NO INJURY TO THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS DESCRIBED AS ¿OK¿. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE PATIENT. THE EVENT OCCURRED ON THE FIRST TREPANATION. THE SURGEON INDICATED THE INITIAL TESTS WERE PERFORMED PRIOR TO FIRST USE. THIS WAS THE INITIAL USE OF THE PERFORATOR. THE CONCOMITANT DEVICE DESCRIPTION WAS PROVIDED WITHOUT THE SERIAL NUMBER AND THE SURGEON¿S FULL NAME WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6982874 ↗