MICRO 100 5053-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854023518), received between Dec 12, 2023 and Dec 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE 00505300900, MICRO 100 DRILL WAS BEING USED ON (B)(6) 2023 DURING A NEUROSURGERY PROCEDURE AND THE ¿MICRO100 HANDPIECE 00505300900 RUNNING AT VARYING SPEEDS WITHOUT THE LEVER BEING ENGAGED. NOT OPERATING AS REQUIRED. SURGEON HAD TO PAUSE PROCEDURE - USED ANOTHER OLDER HANDPIECE TO COMPLETE THE SURGERY.¿. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 15 MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310014 ↗