EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAA (UDI 07898959543357)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07898959543357), received between Sep 10, 2020 and Apr 22, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Remains Activated” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE FIRST HOLE WAS DRILLED WITH NO ISSUE. HOWEVER, THE PERFORATOR PLUNGED AND LACERATED THE DURA WHILE DRILLING THE SECOND HOLE. IT WAS REPORTED THAT THERE WAS A SLIGHT BLEEDING BUT THEY MANAGE TO CONTROL IT. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS TAKEN AND THE PATIENT HAD NO ISSUES POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 11712015 ↗
• MalfunctionNov 17, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE FOR TUMOR, THE PERFORATOR DID NOT DISENGAGE, BUT THE SURGEON WAS ABLE TO STOP THE DEVICE. ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS A 15-MINUTE PROCEDURE DELAY TO CHECK THE CONDITION OF THE PATIENT. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICES. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY, AND THE REPORTED DEVICES ARE STILL BEING HELD IN THE RISKS MANAGEMENT OF THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10857055 ↗
• InjurySep 10, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A RIGHT VENTRICULOPERITONEAL SHUNT REPLACEMENT FOR COMMUNICATING HYDROCEPHALUS, THE PERFORATOR PLUNGED THROUGH THE BONE AND CREATED A TEAR ON THE DURA. ON FOLLOW UP, IT WAS MENTIONED THAT AFTER THE DURA WAS TORN, THE UNDERLYING TISSUES WERE CAUTERIZED. IT WAS ALSO CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 10515266 ↗