Diego Elite MDHP200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925035607), received between Jan 17, 2023 and Aug 25, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Defective 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THERAPEUTIC MASTOIDECTOMY (MASTOID EXPLORATION) THE SURGEON WAS INITIALLY USING THE 5MM ROUND CUTTING BURR (HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY), IT MADE NOISE FROM FRICTION WITH BLACK OILY FLUID COMING OUT OF THE DEVICE AND THE IRRIGATING FLUID TURNED BLACK CONTAINING THE FIELD THAT REQUIRED THE SURGEON TO EXCHANGE THE DEVICE TO A 4MM COURSE BURR. IT WAS REPORTED THE 4MM BURR WAS DIFFICULT TO INSERT AND FRICTION OCCURRED AGAIN, AND THE DEVICE JAMMED WHEN THE SURGEON ATTEMPTED TO EXCHANGE IT OUT (WITH A 2MMB BURR); HOWEVER, THE DEVICE REMAINED OPERABLE, AND THE SURGEON COMPLETED THE PROCEDURE WITH THIS DEVICE BUT OMITTING SOME STEPS IN THE PROCEDURE. THE DEVICE ISSUES RESULTED IN THE PROCEDURE BEING LENGTHENED BY AT LEAST 40 MINUTES. REPORTEDLY, AN ANTIFOG SOLUTION WAS USED AT THE END OF THE PROCEDURE AND THE BURR WAS ABLE TO BE REMOVED. THE IS PATIENT REPORTED TO BE DOING FINE AND NO HEALTH HAZARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627315 ↗
• InjuryJan 17, 2023Defective Device; Defective 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 16186210 ↗
• 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185934 ↗