Diego Elite MBUR6060FRCVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925036536), received between Sep 18, 2022 and Jan 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Aug 3, 2017Open, Classified

   "Chattering" when cutting burrs are used in bone.

   Z-1337-2018 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Break; Break

  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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186237 ↗
• MalfunctionSep 18, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  AS REPORTED , THE 6MM DRILL DEFLECTS IN THE HANDPIECE DURING USE. THE DRILL JUMPS A FEW MILLIMETERS TO THE SIDE. THE PRESSURE WITH THE DRILL ON THE MATERIAL TO BE DRILLED WAS ONLY VERY LOW. THIS HAPPENED SEVERAL TIMES HAPPENED DURING THE SURGERY. EXCESSIVE HEATING WAS NOT DETECTED. THE SHORT, ANGLED HANDPIECE MDASA SN:(B)(4) WAS USED WITH THE MOTOR HANDPIECE EGMDHP200 SN:(B)(4). THE USER THEN USED THE 5MM DRILL EGMBUR5060FRCV IN THE SAME PROCEDURE AND HAD NO PROBLEMS WITH IT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443427 ↗