EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543333)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07898959543333), received between Dec 10, 2019 and Apr 5, 2022 — classified as 16 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (29 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY, WHILE CREATING THE SECOND BURR HOLE IN THE SKULL, THE PERFORATOR DID NOT AUTOMATICALLY STOP ONCE IT MADE IT THROUGH THE SKULL. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014184 ↗
• MalfunctionFeb 17, 2022Failure to Shut Off

  WHILE CREATING THE SECOND BURR HOLE IN THE SKULL, THE PERFORATOR DID NOT AUTOMATICALLY STOP ONCE IT MADE IT THROUGH THE SKULL.

  Patient problems: Insufficient Information

  MAUDE report 13548421 ↗
• MalfunctionOct 11, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING MEDTRONIC LAB TESTING OF THE DEVICE, IT WAS NOTED THAT THE CLUTCH FAILED AND DIDN'T STOP AT A CERTAIN DEPTH ON THE BOVINE SCAPULA. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611588 ↗
• MalfunctionJun 23, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE BIT DID NOT STOP AFTER GOING THROUGH THE CRANIUM. IT WAS NOTED THAT THE PATIENT IS ALIVE BUT WITH INJURY. ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY/IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047914 ↗
• MalfunctionJun 22, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THROUGH MAUDE REFERENCE NUMBER (B)(4) THAT THE CRANIAL PERFORATOR DID NOT STOP AT THE INNER TABLE AND IT WAS MANUALLY STOPPED BY THE SURGEON. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION REGARDING THE FACILITY AND THE EVENT WAS PROVIDED IN THE MAUDE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046589 ↗
• MalfunctionJun 22, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WENT TOO FAR AND DIDN'T STOP AS IT SHOULD HAVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040309 ↗
• MalfunctionApr 20, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING BUR HOLE CREATION, THE PERFORATOR DID NOT STOP. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT AND THERE WAS NO PROCEDURE DELAY. ON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692715 ↗
• InjuryApr 13, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR DID NOT STOP AND DAMAGED THE DURA. IT WAS ALSO CONFIRMED UPON COMPLETION OF THE PROCEDURE, THAT THE BRAIN SURFACE WAS NOT INJURED. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PROCEDURE DELAY, THERE WAS NO BACK-UP DEVICE USED, AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11660760 ↗
• InjuryMar 5, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR PLUNGED ON A SUBDURAL. ON FOLLOW UP, IT WAS REPORTED THAT THE DEVICE DID NOT STOP DURING A SUBDURAL HEMATOMA EVACUATION. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. ON FURTHER FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY AND THE DEVICE IS STILL IN THE HOSPITAL'S RISK MANAGEMENT.

  Patient problems: Perforation

  MAUDE report 11425628 ↗
• InjuryFeb 12, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE EVENT AND THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11325139 ↗
• InjuryJan 20, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP AND CUT THE DURA. IT WAS ALSO REPORTED THAT A PIECE OF BONE LODGED INTO THE BRAIN. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A DEEP BRAIN STIMULATION PROCEDURE AND THERE WAS A 20-MINUTE DELAY IN THE PROCEDURE TO REMOVE THE BONE FROM THE BRAIN. IT WAS ALSO REPORTED THAT THE PATIENT NEED TO REMAIN FLAT FOR 24 HOURS. ON FURTHER FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY AND THE DEVICE WAS DISCARDED.

  Patient problems: Perforation

  MAUDE report 11202105 ↗
• InjuryDec 2, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS REPORTED THAT THE PERFORATOR PLUNGED INTO THE TUMOR THAT WAS SUPERFICIAL. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS CONTINUED NORMALLY WITHOUT DELAY AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Perforation

  MAUDE report 10931584 ↗
• InjuryNov 18, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PERFORATOR DID NOT STOP WHICH CAUSED BLEEDING AND DAMAGE TO THE PATIENT'S DURA. ON FOLLOW UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A VP SHUNT PLACEMENT AND THERE WAS A DELAY ON THE PROCEDURE TO PREVENT BLOOD LOSS. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICES AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 10864128 ↗
• MalfunctionNov 18, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PERFORATOR. NO PATIENT IMPACT REPORTED. ON FOLLOW UP, IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE DEVICE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10863787 ↗
• MalfunctionNov 17, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE AND THERE WAS NO ISSUE WITH THE PATIENT PO ST-SURGERY. IT WAS ALSO REPORTED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856925 ↗
• MalfunctionOct 30, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A REVISION OF LEFT SHUNT VALVE AND TUBING, THE CRANIAL PERFORATOR CONTINUES TO RUN, AND WAS MANUALLY STOPPED BY THE SURGEON. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10762320 ↗
• InjuryOct 5, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WERE NO ADDITIONAL ACTIONS REQUIRED AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 10631924 ↗
• MalfunctionOct 5, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE AND THERE WAS NO DELAY OR ADDITIONAL INTERVENTIONS PERFORMED. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT HIT THE PATIENT'S DURA AND NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Consequences Or Impact To Patient; Perforation

  MAUDE report 10631844 ↗
• InjuryOct 5, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE AND THERE WAS NO DELAY OR ADDITIONAL INTERVENTIONS REQUIRED. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT IMPACT AND THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Consequences Or Impact To Patient; Perforation

  MAUDE report 10628824 ↗
• MalfunctionSep 11, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THE 10-MINUTE DELAY WAS TO PREPARE ANOTHER PERFORATOR TO COMPLETE THE PROCEDURE. IT WAS ALSO MENTIONED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. ALSO, THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE DETAILS OF THE EM200.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521426 ↗
• InjuryAug 27, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS CONFIRMED THAT THE DURA WAS NOT HIT BECAUSE THE BRAIN WAS SUNKEN DUE TO THE SUBDURAL HEMATOMA. NO FURTHER INFORMATION CAN BE PROVIDED FOR THE AD03 DRIVER DETAILS.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10462877 ↗
• InjuryAug 6, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE FOR A TUMOR RESECTION, THE PERFORATOR DID NOT STOP SPINNING WHILE CREATING THE INITIAL BUR HOLE. IT HAPPENED WHILE PASSING THROUGH THE SKULL THUS PLUNGING INTO THE TISSUE. IT WAS ALSO ADDED THAT THERE WAS A PROCEDURE DELAY TO CONTROL THE BLEEDING. THE REMAINING BUR HOLES WERE COMPLETED USING AN ACRA-CUT PERFORATOR. ON FOLLOW UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 10376638 ↗
• InjuryAug 4, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THROUGH MAUDE REFERENCE NUMBER (B)(4) THAT THE PERFORATOR FAILED TO STOP AT DURA LEVEL WHICH RESULTED TO DURA CONTUSION. IT WAS ALSO ADDED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. NO FURTHER INFORMATION REGARDING THE FACILITY AND THE EVENT WAS PROVIDED IN THE MAUDE REPORT.

  Patient problems: Contusion; Perforation

  MAUDE report 10364869 ↗
• MalfunctionJun 24, 2020Failure to Auto Stop

  THE CRANIAL PERFORATOR DIDN'T STOP AT THE INNER TABLE; IT WAS MANUALLY STOPPED BY THE SURGEONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10188821 ↗
• InjuryJun 17, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR MALFUNCTIONED. NO PATIENT IMPACT REPORTED. ON FOLLOW UP, IT WAS CONFIRMED THAT THE CLUTCH OF THE PERFORATOR DID NOT WORK CAUSING DURA DAMAGE.

  Patient problems: Perforation

  MAUDE report 10165420 ↗