EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm DM0011FAA (UDI 07898959543173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07898959543173), received between Dec 18, 2020 and May 20, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Device Remains Activated; Device Remains Activated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352728 ↗
• InjuryApr 19, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE CORPUS CALLOSOTOMY THE PERFORATOR BURR FAILED TO STOP ONCE INNER MOST BI CORTICAL LAYER OF THE CRANIUM DUE TO WHICH DURA WAS DAMAGED. IT WAS REPORTED THAT THE PRODUCER GOT DELAYED FOR 30 MINUTES TO 1 HOUR AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT.

  Patient problems: Perforation

  MAUDE report 19141374 ↗
• InjuryNov 3, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY/TUMOR RESECTION CASE, THE SURGEON WAS DRILLING 3 HOLES USING THE PERFORATOR. THE FIRST 2 HOLES WENT FINE, HOWEVER WHILE DRILLING THE THIRD HOLE IT WAS REPORTED THAT INSTRUMENT SEEMED TO PLUNGE FORWARD AND ENDED UP HITTING THE DURA OF THE PATIENT. NO SIGNIFICANT PATIENT HARM WAS REPORTED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO ADDITIONAL ACTION TAKEN TO PREVENT IMPACT OR INJURY AND THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 15723077 ↗
• InjuryAug 19, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY PERFORATOR DID NOT STOP, DURA WAS DAMAGED AND ALSO INJURY TO THE CORTICAL SURFACE OCCURRED. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURE DELAY OF 30 MINUTES FOR DURA RE-CONSTRUCTION. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: Brain Injury; Perforation

  MAUDE report 15260062 ↗
• InjuryMar 17, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR PERFORATED THE DURA ON A COVID POSITIVE PATIENT. IT WAS ALSO STATED THAT DRILL WENT THROUGH THE DURA AND CAUSED BLEEDING. BLEEDING WAS STOPPED SHORTLY, AND THE CASE CONTINUED. THERE IS A DELAY IN PROCEDURE OF LESS THAN ONE HOUR AND NO RECORD OF ANY POST PROCEDURE PATIENT IMPACT ASSOCIATED WITH THE DEVICE. DATE OF NOTIFICATION: 2022-02-15.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13793257 ↗
• InjuryJun 10, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A MINIMAL PROCEDURE DELAY OF 2 TO 5 MINUTES TO WORK ON THE BURR HOLES AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO ADDITIONAL ACTIONS TAKEN BECAUSE OF THE EVENT AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11980067 ↗
• MalfunctionMay 13, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS ALSO REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE AND THERE WAS A 5-MINUTE PROCEDURE DELAY TO REPLACE THE DEVICE. THERE WAS NO FURTHER INFORMATION REGARDING THE CURRENT STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820016 ↗
• InjuryFeb 11, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PERFORATOR DID NOT STOP AND DAMAGED THE DURA. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PATIENT HAD NO ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11314192 ↗
• MalfunctionFeb 5, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED, NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11289112 ↗
• MalfunctionDec 18, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR PLUNGED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP AND DRILLED FURTHER THAN IT SHOULD HAVE DURING A CRANIOTOMY FOR A TUMOR. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL NON-ROUTINE ACTIONS NEEDED, NO PROCEDURE DELAY, AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11039836 ↗