EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543586)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07898959543586), received between Sep 1, 2023 and Jul 11, 2024 — classified as 6 injuries, 3 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.

• InjuryJul 11, 2024Device Remains Activated; Device Remains Activated

  ON FOLLOW UP IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY DISCHARGED TO HOME TREATMENT.

  Patient problems: Perforation; Spinal Cord Injury

  MAUDE report 19717977 ↗
• MalfunctionMay 20, 2024Device Remains Activated; Device Remains Activated

  ON FOLLOW UP IT WAS REPORTED THAT THE PATIENT WERE NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352643 ↗
• InjuryMay 7, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIO, FOR TUMOR THE TIP OF THE DRILL DIDN'T STOP. IT WAS REPORTED THAT THE PATIENT SUFFERED A SIGNIFICANT INJURY AND BRAIN HEMATOMA LEADING TO SEIZURE. THE PATIENT IS CURRENTLY IN THE ICU BUT IS EXPECTED TO RECOVER, WITH POSSIBLE DEFICITS. ON FOLLOW UP IT WAS REPORTED THAT THE PATIENT SUFFERED A MODERATE/SEVERE CONTUSION, BLEED AND WAS TRANSPORTED TO ICU AND REMAINED INTUBATED AND SEDATED.

  Patient problems: Bruise/Contusion; Convulsion/Seizure; Hematoma; Intracranial Hemorrhage

  MAUDE report 19259151 ↗
• MalfunctionApr 22, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE PERFORATOR. NO PATIENT IMPACT WAS REPORTED. ON FOLLOWUP IT WAS REPORTED THAT DURING THE CRANIAL TUMOR RESECTION THE PERFORATOR DID NOT STOP AND THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS REPORTED THAT THERE WAS DELAY IN PROCEDURE FOR 15 MINUTES TO ENSURE THAT THERE WAS NO IMPACT TO THE PATIENT AND THERE WAS NO INTERVENTION OR ADDITIONAL SURGERY PERFORMED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154548 ↗
• MalfunctionMar 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN PERFORMING THE CRANIOTOMY ON THE RIGHT SIDE, THE DEVICE FUNCTIONED CORRECTLY AND STOPPED BEFORE REACHING THE DURA, BUT WHEN PERFORMING THE TREPANANTION ON THE LEFT SIDE, THE DEVICE DID NOT STOP BEFORE REACHING DURA.IT WAS REPORTED THAT PATIENT WAS ALIVE WITH NO INJURY AND THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE. ON FOLLOW UP IT WAS REPORTED THAT A PROCEDURE OF 1 BILATERAL DEEP BRAIN STIMULATION WITH RECHARGEABLE BATTERY WAS PERFORMED AND THE PATIENT'S CONDITION AFTER THE PROCEDURE IS GOOD. IT WAS ALSO REPORTED THAT THERE WAS DELAY OF THE SURGICAL INTERVENTION FOR 90 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864846 ↗
• InjuryJan 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DIDN'T STOP WHEN IT REACHED THE DURA MATER AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. ON FOLLOW UP IT WAS CONFIRMED THAT THE PERFORATOR HAS ENTERED SUBDURAL HEMATOMA AND DUE TO THE EVENT THERE WAS NO DELAY IN PROCEDURE AND NO INTERVENTION PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DOING GOOD AFTER THE OPERATION.

  Patient problems: Perforation

  MAUDE report 18462428 ↗
• InjuryJan 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR "PLUNGED" INTO THE PATIENT AND WAS UNDER THE IMPRESSION IT WENT THROUGH THE DURA. IT WAS ALSO REPORTED THAT THE POST, THE PATIENT IS DOING GOOD. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED-UP.

  Patient problems: Perforation

  MAUDE report 18461922 ↗
• InjuryNov 20, 2023Misconnection; Device Remains Activated; Misconnection; Device Remains Activated

  IT WAS REPORTED THAT DURING THE DBS LEAD PLACEMENT PROCEDURE THE CLUTCH NEVER ENGAGED ON THE PERFORATOR BIT AND INJURED THE PATIENT. IT WAS REPORTED THAT THE SURGEON NOTICED THE DRILL DID NOT STOP AND INTERVENED. THERE WAS PROCEDURE DELAY FOR CHANGING THE SURGICAL PLAN ENTIRELY, AND THE DEVICE COULD NO LONGER PLACE A LEAD ON THAT SIDE. ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S).

  Patient problems: Perforation

  MAUDE report 18168292 ↗
• InjurySep 1, 2023Loss of Power; Device Remains Activated; Loss of Power; Device Remains Activated

  IT WAS REPORTED THAT DURING AWAKE DBS PROCEDURE, A CORTICAL DEFECT OCCURRED AS THE CRANIOTOME DID NOT STOP IN TIME. IT WAS REPORTED THAT THERE WAS NO INTERVENTION PERFROMED AND THERE WAS NO PROCEDURE DELAY. IT WAS REPORTED THAT POST OPERATION, THE PATIENT WAS ALIVE WITH NO INJURY. ON FOLLOW-UP IT WAS REPORTED THAT, THE INJURY APPEARS TO HAVE BEEN CAUSED WITH THE REUSABLE OTHER MANUFATURER PERFORATOR (MANUFACTURED BY BBRAUN), TO CONTINUE THE PROCEDURE THEY USED THE DISPOSABLE AND THE THE PLASTIC HOUSING DIDN'T STOP AND SPINNING. IT WAS ALSO REPORTED THAT THE ATTACHEMENT IS WORKING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 17669382 ↗