EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm DM0011FAA (UDI 07898959543562)Recalls & reported problems
Micromar Indústria e Comércio Ltda · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07898959543562), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Remains Activated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Remains Activated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Device Remains Activated
IT WAS REPORTED THAT WHEN TESTING THE DEVICE, THE PHYSICIAN NOTICED THAT IN THE MOMENT WHEN PERFORATOR REACHED SOFT TISSUE AND SUPPOSE TO STOP, IT IS TWISTING AND CAUSING RESISTANCE TO OPERATOR. THIS HAPPENED THREE TIMES IN A ROW. DUE TO TWISTING, CABLE OF THE MOTOR TWISTS AROUND MOTOR IN THAT MOMENT. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494151 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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