EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAA (UDI 07898959543180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07898959543180), received between Nov 9, 2020 and May 12, 2022 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP WHEN IT HIT THE BONE AND DAMAGED THE DURA. IT WAS REPORTED THAT THERE WAS SMALL AMOUNT OF BLEEDING AS A RESULT OF THIS EVENT AND THERE WAS A PROCEDURE DELAY OF 2 MINUTES TO STOP THE BLEEDING. DURING THE DELAY SURGEON DID COAGULATION WITH THE BIPOLAR CAUTERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Spinal Cord Injury

  MAUDE report 14377987 ↗
• InjuryApr 26, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN USING PERFORATOR TO DRILL BURR HOLE INTO SKULL, IT CUT THROUGH SO QUICKLY AND CUT STRAIGHT THROUGH DURA AND THE CLUTCH MECHANISM DID NOT ACTIVATE. IT WAS REPORTED THAT THERE WAS DURA TEAR OF THE PATIENT BUT THERE WAS NO INTERVENTION PERFORMED. THE REST OF THE PROCEDURE WAS CARRIED OUT WITH THE HELP OF BACK UP DEVICE. THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 14210559 ↗
• MalfunctionAug 10, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE FOR A SUBDURAL HEMATOMA OF A TRAUMA PATIENT, THE PERFORATOR DID NOT STOP. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PROCEDURE WAS COMPLETED USING A COMPETITIVE PERFORATOR. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A SHORT DELAY (LESS THAN 3 MINUTES) DUE TO RETRIEVAL AND PREPARATION OF A CODMAN PERFORATOR TO COMPLETE THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304344 ↗
• InjuryAug 3, 2021Device Remains Activated; Device Remains Activated

  ON FURTHER FOLLOW UP IT WAS REPORTED THAT PROCEDURE IS CRANIOTOMY AND THEY NEED TO REPAIR DURA AND SOME DAMAGE IN TISSUE DURING THE DELAY.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 12270680 ↗
• InjuryJul 30, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE SERIAL NUMBERS OF THE EM200 AND AD03. IT WAS ALSO REPORTED THAT THE EM200 AND AD03 WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Perforation

  MAUDE report 12257012 ↗
• InjuryJun 10, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHILE DRILLING FOR A BUR HOLE, THE PERFORATOR DID NOT STOP AND TEAR THE DURA. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11980002 ↗
• MalfunctionMay 10, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR DID NOT STOP. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION PERFORMED, NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING A BACK-UP PRODUCT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802982 ↗
• InjuryApr 27, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING BIOPSY, AN EM200 AND AD03 WERE USED TOGETHER WITH AN EASYDRILL WHICH DID NOT STOP AND RUPTURED THE DURA MATER. IT WAS REPORTED THAT THERE WERE BONE FRAGMENTS THAT WENT INTO THE INTRACRANIAL SPACE BUT THESE FRAGMENTS WERE ALL REMOVED. IT WAS ALSO REPORTED THAT THERE WAS A 10-MINUTE PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCTS. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE 10-MINUTE PROCEDURE DELAY WAS SPENT TO REMOVE ALL BONE FRAGMENTS INSIDE THE INTRACRANIAL SPACE. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE SERIAL NUMBERS OF THE MOTOR AND THE ATTACHMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11734897 ↗
• MalfunctionFeb 8, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DIDN'T STOP AFTER DRILLING THE CORTEX. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE EVENT HAPPENED DURING A SUBDURAL HEMATOMA PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED, THERE WAS NO PATIENT IMPACT, AND THE PATIENT HAD NO ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294590 ↗
• MalfunctionJan 6, 2021Device Remains Activated; No Apparent Adverse Event; Device Remains Activated; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A PROBLEM WHILE USING THE DEVICE. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126337 ↗
• InjuryDec 29, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING TREPANATION, THE DEVICE DID NOT STOP WHICH RESULTED TO PERFORATION. HOWEVER, IT DID NOT CAUSE BRAIN INJURY.

  Patient problems: Perforation

  MAUDE report 11088140 ↗
• MalfunctionDec 9, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR DID NOT STOP. HOWEVER, THERE WAS NO ADDITIONAL INTERVENTION, THERE WAS NO PROCEDURE DELAY AND IT WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976580 ↗
• InjuryNov 26, 2020Device Remains Activated; Device Remains Activated

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

  Patient problems: Perforation

  MAUDE report 10909351 ↗
• InjuryNov 9, 2020Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS CONFIRMED THAT THE DEVICE HAS BEEN DISCARDED BY THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient; Perforation

  MAUDE report 10811683 ↗