EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm DM0011FAA (UDI 07898959543340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07898959543340), received between Jun 22, 2021 and Sep 18, 2024 — classified as 1 injury, 1 malfunction.

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 18, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY, WHILE PERFORATOR WAS FAILED PLUNGED AND DAMAGED DURA IN PAEDIATRIC. IT WAS ALSO REPORTED THAT THERE WAS 30 MINS DELAY.

  Patient problems: Perforation

  MAUDE report 20243402 ↗
• MalfunctionJun 22, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PERFORATOR. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THE PERFORATOR DID NOT STOP WHEN DRILLING THE BURR HOLE AND THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12039085 ↗