EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07898959543081), received between Mar 16, 2017 and Jun 22, 2021 — classified as 34 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (35 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY, THE PERFORATOR DID NOT STOP. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITH NO NON ROUTINE OR ADDITIONAL INTERVENTION. IT WAS ALSO STATED THAT THE DEVICE WAS DESTROYED AND WILL NO LONGER BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038902 ↗
• MalfunctionJun 22, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIAL PROCEDURE, THE DEVICE CONTINUES TO RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO ADDITIONAL/NON ROUTINE PROCEDURE TAKEN AS A RESULT OF THE EVENT. NO FURTHER INFORMATION CAN BE PROVIDED ON THE SURGERY AND THE STATUS OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038638 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR STOPPED, HOWEVER, THE TORQUE WAS TRANSMITTED TO THE ATTACHMENT INCLUDING THE MOTOR AND ROTATES IN THE SURGEON'S HAND. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY ON THE PROCEDURE AND IT WAS COMPLETED USING THE REPORTED DEVICE. ON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT BLEED FOR MINUTES BUT IT WAS CONTROLLED BY THE SURGEON. ON FURTHER FOLLOW UP, NO ADDITIONAL INFORMATION CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT AND THE PERFORATOR WILL NOT BE RETURNED AS IT HAS BEEN DESTROYED BY THE CUSTOMER. THEY ALSO ADDED THAT AN EM100-A AND AN ADO3 WAS USED DURING THIS EVENT, HOWEVER, THERE WAS NO FURTHER INFORMATION REGARDING THE SERIAL NUMBERS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10936794 ↗
• InjuryAug 31, 2020Device Remains Activated; Device Remains Activated

  ON FURTHER FOLLOW UP, IT WAS REPORTED THAT THE PROCEDURE TIME WAS LENGTHENED DUE TO THE EVENT BUT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. IT WAS ALSO ADDED THAT THE DEVICE WAS DISCARDED.

  Patient problems: Perforation

  MAUDE report 10474859 ↗
• InjuryMay 26, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE CREATION OF THE 1ST AND 2ND BURR HOLE FOR A BRAIN TUMOR RESECTION, THE CLUTCH MECHANISM OF THE PERFORATOR DIDN¿T WORK AND STOP ON TIME CAUSING DURA DAMAGE. IT WAS ALSO ADDED THAT THE PERFORATOR WORKED PROPERLY ON THE OTHER 3 BURR HOLES. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 10086525 ↗
• MalfunctionFeb 13, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT THE CRANIAL PERFORATOR PENETRATES THE DURA. ON FOLLOW UP, IT WAS REPORTED THAT THE PROBLEM WAS DIFFICULTY IN CONNECTING THE PERFORATOR. IT WAS ALSO REPORTED THAT THE PERFORATOR MAY HAVE BEEN USED IN MULTIPLE PROCEDURES AND THERE WAS NO PATIENT INJURY OR IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708760 ↗
• InjuryNov 13, 2019Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS MENTIONED THAT A DURA SUBSTITUTION WAS PERFORMED AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 9314699 ↗
• InjuryOct 10, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE CRANIAL PERFORATOR DEVICE DAMAGED THE DURA MATER. ADDITIONAL INTERVENTION WAS COMPLETED TO RESOLVE THE DAMAGED DURA MATER. ADDITIONAL INFORMATION IS BEING FOLLOWED UP ON THE PATIENT STATUS.

  Patient problems: Perforation

  MAUDE report 9176606 ↗
• InjurySep 25, 2019Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS AN ADDITIONAL INTERVENTION DONE TO RESOLVE THE DAMAGED DURA. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Consequences Or Impact To Patient; Perforation

  MAUDE report 9120875 ↗
• InjurySep 20, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON THE LEFT TEMPORAL FOR NEOPLASIA PROCEDURE. DURING THE SURGERY, THE CRANIAL PERFORATOR WENT OUT TOO LATE WHICH OPENED 1CM OF THE DURA-MATER. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP.

  Patient problems: Perforation

  MAUDE report 9101059 ↗
• InjuryAug 30, 2019Device Remains Activated; Device Remains Activated

  ON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY AND THE DEVICE WAS ALREADY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 8952631 ↗
• InjuryAug 20, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR PLUNGED DURING A CRANIOTOMY PROCEDURE. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: Perforation

  MAUDE report 8913348 ↗
• InjuryJul 11, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING BURR HOLE DRAINAGE PROCEDURE, CRANIAL PERFORATOR DID NOT DISENGAGE AND PLUNGED THROUGH THE SKULL. DAMAGE TO THE BRAIN TISSUE WAS PREVENTED BY THE PATIENT'S CHRONIC SUBDURAL HEMATOMA. ON FOLLOW UP, IT WAS MENTIONED THAT NO FURTHER INFORMATION CAN BE PROVIDED REGARDING DEVICE DETAILS AND PATIENT STATUS.

  Patient problems: Perforation

  MAUDE report 8780799 ↗
• InjuryJul 2, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR CUTTER DID NOT STOP ROTATING AFTER BURRING A HOLE DURING PROCEDURE. ON FOLLOW UP, IT WAS REPORTED THAT IT HIT AND DAMAGED THE PATIENT'S DURA. IT WAS ALSO MENTIONED THAT THERE WAS A DELAY ON THE PROCEDURE TO GET A NEW HAND DRILL. THE PATIENT IS FINE AS THE SURGERY WAS COMPLETED BY A NEW DEVICE. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED REGARDING PRODUCT RETURN.

  Patient problems: Perforation

  MAUDE report 8753462 ↗
• InjuryJun 27, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DRILL DID NOT STOP WHILE MAKING THE THIRD BURR HOLE. THE BONE WAS HEALTHY, HAD NO RECESSES AND VERY THICK. AFTER A POST OPERATIVE CT SCAN IT WAS CONFIRMED THAT THERE WAS A SMALL BRAIN CONTUSION CAUSED BY THE INCIDENT. DEVELOPMENTS WERE OBSERVED TO ASSESS WHETHER THERE WAS ANY KIND OF DAMAGE BROUGHT ABOUT BY THE ISSUE. ON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT IS WELL. THERE WAS A SLIGHT EDEMA IN THE RIGHT HEMISPHERE BUT IT WAS A RESULT OF THE SURGERY ITSELF. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED REGARDING PRODUCT RETURN.

  Patient problems: Contusion

  MAUDE report 8739197 ↗
• InjuryJun 25, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE EASY DRILL DID NOT STOP AND HIT THE DURA MATER. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED REGARDING PRODUCT RETURN AND PATIENT IMPACT.

  Patient problems: Perforation

  MAUDE report 8730455 ↗
• InjuryJun 25, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR TOOL DID NOT STOP. IT WAS STATED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS CONFIRMED WITH FACILITY THAT THE DEVICE TOUCHED AND DAMAGED THE DURA DURING THE OPERATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730450 ↗
• InjuryJun 5, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A TUMOR RESECTION SURGERY, THE PERFORATOR DID NOT STOP RESULTING IN A DURA TEAR WITH BLEEDING AND LITTLE CORTICAL DAMAGE OF THE CEREBELLUM. EM200 AND AD03 WERE USED TOGETHER WITH THE PERFORATOR AND THE RPM OF THE IPC WAS SET TO 70000 RPM. IT WAS NOTED THAT THERE WAS A 30 MINUTE-DELAY IN THE PROCEDURE BUT IT WAS COMPLETED WITH A BACK UP DEVICE. ON FOLLOW UP, IT WAS CONFIRMED THAT THE DELAY WAS TO STOP THE BLEEDING AND TO GET A NEW PERFORATOR TO CONTINUE THE SURGERY. THERE WERE NO ADDITIONAL, NON ROUTINE ACTIONS TAKEN. PATIENT IS ALIVE WITH NO SECONDARY EFFECTS. IT WAS ALSO MENTIONED THAT THERE WERE NO ISSUES WITH THE MOTOR AND THE AD03 AND THE ONLY DEVICE THAT WILL BE RETURNED FOR ANALYSIS IS THE PERFORATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 8671737 ↗
• InjuryMay 14, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHILE MAKING THE ENTRY HOLE TO START WITH A DBS PROCEDURE, THE PERFORATOR DID NOT STOP AND THE DURA WAS DAMAGED. THE PROCEDURE WAS PERFORMED AND COMPLETED WITH THE REPORTED PRODUCT. IN COMPLIANCE WITH THE COUNTRY'S HEALTH AUTHORITY PROCEDURES, THE HOSPITAL WILL BE KEEPING THE DEVICE FOR A MONTH, AND WILL BE RETURNED FOR REPAIR AFTERWARDS. ON FOLLOW-UP, IT WAS CONFIRMED WITH THE HCP THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 8609102 ↗
• InjuryApr 26, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP AND DAMAGED THE DURA. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT IS HEALTHY AND WELL. IT WAS ALSO CONFIRMED WITH THE FACILITY THAT THERE WAS NO DELAY IN THE PROCEDURE AND THAT THERE ARE NO ADDITIONAL/NON-ROUTINE ACTIONS TAKEN AFTER THE EVENT.

  Patient problems: Perforation

  MAUDE report 8554998 ↗
• InjuryApr 26, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THE PERFORATOR DID NOT STOP AND DAMAGED THE DURA. ON FOLLOW UP, IT WAS MENTIONED THAT THERE WERE NO ADDITIONAL NON ROUTINE PROCEDURES TAKEN AND THERE WAS NO DELAY ON THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THERE WILL BE NO REVISION SURGERY. NO ADDITIONAL INFORMATION ABOUT THE CURRENT STATUS OF THE PATIENT HAS BEEN PROVIDED.

  Patient problems: Perforation

  MAUDE report 8554915 ↗
• InjuryOct 9, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A BURR HOLE WAS MADE AND THE PERFORATOR DID NOT STOP TEARING THE DURA-MATER AND BRAIN IN THE ROLANDIC AREA. PATIENT IS ALIVE WITH INJURY. ACCORDING TO PHYSICIAN, PATIENT HAD SLIGHT PARESIS AND CONTUSION FOCUSING ON ROLANDIC (MOTOR) AREA. ON FOLLOW UP, IT WAS REPORTED AND CONFIRMED WITH HCP THAT THERE WAS A 40 MINUTE DELAY TO STOP THE BLEEDING AND RE-ESTABLISH THE SURGICAL FIELD IN ORDER TO CONTINUE THE SURGERY. SURGERY WAS CONTINUED AND BIOPSY WAS DONE. PATIENT RECOVERED, AS EXPECTED, AND HAS ALREADY LEFT THE HOSPITAL.

  Patient problems: Contusion; Hemorrhage/Blood Loss/Bleeding; Paresis

  MAUDE report 7946779 ↗
• InjuryOct 9, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DISPOSABLE PORTION OF THE EASY DRILL DID NOT STOP PERFORATING AND WENT RIGHT TO THE BRAIN. THE PERFORATOR SHOULD HAVE STOPPED ONCE IT BROKE THROUGH THE BONE BUT DID NOT STOP. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE DURA GOT CUT AND THE PATIENT HAD SUBDURAL HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 7946713 ↗
• InjurySep 7, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT SURGEON WAS EXPERIENCING THAT THE CRANIAL PERFORATOR EASY DRILL DID NOT STOP AND DAMAGED THE DURA. ON FOLLOW UP IT WAS CONFIRMED THIS OCCURED BACK IN (B)(6) 2018 AND WAS NOT REPORTED TO THE DEVICE MANUFACTURER. IT WAS ALSO NOTED THAT THIS MAY HAVE OCCURRED WITH TWO DIFFERENT SURGEONS AT THIS HOSPITAL BUT THIS HAS NOT BEEN CONFIRMED. IT WAS REPORTED THAT THE CURRENT CONDITION OF THE PATIENT IS STABLE.

  Patient problems: Perforation

  MAUDE report 7857510 ↗
• InjuryApr 22, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT DISENGAGE. NO PATIENT IMPACT REPORTED. ON FOLLOWUP IT WAS REPORTED THAT THERE WAS A DELAY IN THE SURGERY DUE TO REPAIR OF CRANIAL LESION HOWEVER IT WAS ALSO STATED THAT CURRENT STATUS OF THE PATIENT IS ALIVE WITH INJURY. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED.

  Patient problems: Perforation

  MAUDE report 7449771 ↗