EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAA (UDI 07898959543074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07898959543074), received between Jan 16, 2019 and Sep 20, 2019 — 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.

• InjurySep 20, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING SURGERY, THE PERFORATOR DID NOT STOP CAUSING A CEREBRAL LESION. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WERE NO ADDITIONAL NON-ROUTINE ACTIONS REQUIRED, NO DELAY IN THE PROCEDURE AND THE PATIENT HAD NO ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 9101036 ↗
• InjuryJan 16, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR PLUNGED AND CLUTCH DIDN¿T ENGAGE. PATIENT¿S DURA WAS COMPROMISED. THERE WAS A 3 MINUTE DELAY DUE TO OPENING A NEW PERFORATOR FOR SUBSEQUENT BUR HOLES. FURTHER FOLLOW-UP IS BEING PERFORMED ON EVENT AND PATIENT'S CONDITION.

  Patient problems: Perforation

  MAUDE report 8252271 ↗