EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543470)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07898959543470), received between Mar 10, 2023 and Feb 27, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR FAILED TO STOP IN THE PRESENCE OF DURA MATER DURING CRANIOTOMY. IT WAS REPORTED THAT THE PATIENT WAS ALIVE, WITH NO INJURY, PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE P ROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789737 ↗
• MalfunctionDec 6, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE LEFT PARIETAL, SENSORY COMPLEX SUPRATENTORIAL BRAIN ARTERIOVENOUS MALFORMATION RESECTION SURGERY THE PERFORATOR DID NOT STOP AUTOMATICALLY AS IT WENT THROUGH THE BONE. TWO BURR HOLES MADE AND SAME ISSUE OCCURRED WITH BOTH BURR HOLES. THE PERFORATOR WAS CHANGED. THERE WAS NO FURTHER ISSUE WITH THE REPLACEMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273472 ↗
• MalfunctionAug 25, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DRILL DID NOT STOP IN TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622035 ↗
• InjuryJul 26, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIAL SURGERY THE PERFORATOR BRAKE DID NOT WORK. IT WAS ALSO REPORTED THAT DURA MATER IS DAMAGED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: Spinal Cord Injury

  MAUDE report 17395649 ↗
• InjuryJun 6, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP AND TORN THE DURA. IT WAS REPORTED THAT THERE WAS NO FURTHER IMPACT TO THE PATIENT AND THE DEVICE DID NOT HIT THE BRAIN.

  Patient problems: Perforation; Spinal Cord Injury

  MAUDE report 17069266 ↗
• MalfunctionMay 24, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING IMPLANTATION OF ELECTRODES FOR DEEP BRAIN STIMULATION SURGERY, THE DRILL CONTINUES TO RUN. IT WAS ALSO REPORTED THAT THE SPECIALIST DETECTED THE ANOMALY AND TURNED OFF THE DRILL MANUALLY DUE TO WHICH THERE WAS NO PERFORATION OF DURA MATER. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED DUE TO THE EVENT. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990353 ↗
• InjuryMay 8, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE PROCEDURE OF NAVIGATED BIOPSY, PERFORATOR WOULDN'T STOP AND IT CUT INTO THE PATIENTS BRAIN. IT WAS ALSO REPORTED THAT THERE WAS A DELAY IN THE SURGICAL PROCEDURE TO CONTROL THE BLEEDING AND AFTER THE OPERATION THE PATIENT WAS TAKEN TO INTENSIVE CARE UNIT AND GOT A COMPUTED TOMOGRAPHY SCAN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT IS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16885035 ↗
• InjuryApr 27, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY THE PERFORATOR FAILED TO STOP ONCE IT PERFORATED THE SKULL AND CAUSED SOFT TISSUE DAMAGE TO THE BRAIN. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT AND THERE WAS NO PROCEDURE DELAY. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 16822181 ↗
• InjuryMar 10, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP WHEN THE INNER DRILL BROKE THROUGH THE CRANIAL CORTEX. INSTEAD IT PLUNGED THROUGH THE DURA INTO THE CORTEX OF THE BRAIN CAUSING PATIENT INJURY. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Perforation

  MAUDE report 16520361 ↗