Diego Elite MDSSARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925035614), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryJan 17, 2023Overheating of Device; Overheating of Device

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE WITH THE SHORT MASTOID ATTACHMENT, BECAME SUFFICIENTLY HOT TO BURN THROUGH METAL AND CAUSED SEVERE, FIRST-DEGREE BURNS WITH BLISTERING TO THE PHYSICIAN'S TWO FINGERS DURING A THERAPEUTIC MASTOID PROCEDURE FOR CHOLESTEATOMA. THE BURNS WERE TREATED WITH COLD APPLICATION. THE PHYSICIAN HAD ONLY BEEN USING IT FOR LESS THAN A MINUTE. THE HAND PIECE REPORTEDLY STARTED SMOKING AND SMELLED LIKE BURNING METAL SIMILAR TO A FIRED GUN. IN ADDITION, THE BURR PIECE BROKE INSIDE THE HANDPIECE. THE PHYSICIAN ATTEMPTED TO USE ANOTHER OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE BUT THERE WERE MORE "ISSUES" NOTED AND THE DIEGO ELITE SYSTEM CONSOLE REPORTEDLY "MALFUNCTIONED" AS WELL. THE CUSTOMER BELIEVED THAT THE SECOND HANDPIECE WAS INCORRECTLY ATTACHED TO THE CONSOLE AND ATTRIBUTED THE ISSUE TO EITHER THE CONSOLE OR USER ERROR. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED. CASE WITH PATIENT IDENTIFIER: (B)(6) REPORTS THE FIRST OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE. CASE WITH PATIENT IDENTIFIER: (B)(6) REPORTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16187068 ↗