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Diego Elite MDASARecalls & reported problems

Gyrus ACMI, LLC · DRILL, ATTACHMENT ANGLED, SHORT Diego Elite Drill · Class 2

Data updated Oct 13, 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 00821925035621), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Overheating of Device1
  • Smoking1

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.

  • MalfunctionSep 13, 2022Overheating of Device; Smoking; Overheating of Device; Smoking

    AS REPORTED, THE DRILL IN THE HANDPIECE IS TRIGGERED. THE HANDPIECE BECAME VERY HOT DURING THE PROCEDURE AND SMOKE WAS PRODUCED. THIS PROLONGED THE OPERATING TIME. THE CUSTOMER WAS ABLE TO CONTINUE WITH HIS OWN SYSTEM". THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15408739 ↗

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources and updates

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