EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm DM0008FAA (UDI 07898959543166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07898959543166), received between Jun 22, 2021 and Jul 18, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PRODUCT DID NOT WORKED VERY WELL, THE FUNCTION WAS NOT WORKING AND. PRODUCT HAS TO STOP DRILLING BUT PRODUCT DID NOT STOPPED. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - WITH INJURY AND DURA MATER WAS INJURED. FORTUNATELY, THE SURROUNDING BRAIN TISSUE WAS NOT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). ON FOLLOWUP IT WAS REPORTED THAT THE PATIENT IS ALIVE, NOT HARMED IN A BAD WAY WITH CONSEQUENCES.

  Patient problems: Spinal Cord Injury

  MAUDE report 19777627 ↗
• MalfunctionAug 8, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE EXECUTION OF PERFORATION HOLE, THE PERFORATOR FELL THROUGH DURA WITHOUT STOP. IT WAS REPORTED THAT HEALTH CARE PROFESSION STOPPED THE PROCEDURE IN TIME AND NO THE PATIENT HARM WAS OCCURED. IT WAS ALSO REPORTED THAT CRANIAL TREPANATION INTERVENTION WAS PERFORMED AND PROCEDURE COMPLETED WITH BACKUP PRODUCT. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS A DELAY IN PROCEDURE FOR 5 MINUTES AND THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478900 ↗
• InjuryApr 10, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY PROCEDURE, THE TIP OF THE PEDIATRIC PERFORATOR DID NOT STOP WHEN IT REACHED THE DURA AND BREACHED A GAP IN THE DURA, BRUISING THE CORTEX OF THE F1 GIRUS. IT WAS ALSO REPORTED THAT THE DETAILS OF THE PROCEDURE WAS SKULL TUMOR ABLATION. ON FOLLOWED-UP IT WAS REPORTED THAT THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THIS EVENT AND THERE WERE STILL BONE FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient; Spinal Cord Injury

  MAUDE report 16705896 ↗
• InjuryApr 4, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE SURGEON OPERATED THE PRODUCT CORRECTLY AND THE PERFORATOR DID NOT STOP, LEAVING THE SMALL BONE DISC AS EXPECTED. THE ENTIRE SHAFT OF THE PERFORATOR WAS PLUNGED THROUGH THE SKULL REQUIRING THE SURGEON TO ENLARGE THE HOLE TO DEAL WITH BLEEDING AND BRAIN PENETRATION. IT WAS ALSO REPORTED THAT THERE WAS A DELAY IN PROCEDURE FOR ABOUT 10 MINUTES AND PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. ON FOLLOW UP IT WAS REPORTED THAT THE PROCEDURE WAS VENTRICULO PERIOTNEAL SHUNT IMPLANT AND THE PATIENT CONDITION WAS STABLE AND SENT TO RECOVERY PER TYPICAL POST OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13995238 ↗
• MalfunctionNov 7, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT AN EASYDRILL TRAINING WAS ORGANIZED AND CONDUCT A SURGICAL TECHNIQUE USING A 3D SKULL MODEL. THEY DRILLED SEVERAL HOLES WITH DIFFERENT PERFORATORS AND OUT OF THE 18 HOLES MADE USING TWO DM0008FAA (L/N: 482/20), ONLY ONE PERFORATOR CREATED 4 PLUNGES. IT ALSO REPORTED THAT SEVERAL HOLES WERE MADE USING DM0011FAA (L/N: 462/20) AND SOME HOLES PLUNGES THROUGH THE 3D MODEL. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763461 ↗
• MalfunctionJun 22, 2021Device Remains Activated; Intermittent Loss of Power; Device Remains Activated; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PERFORATOR STOPPED SEVERAL TIMES DURING TREPANATION BUT THE ANATOMICAL STOP DID NOT TAKE PLACE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046696 ↗