E9000 E8165LSORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854010471), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionNov 4, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE E8165LSO, 6.5 X 38MM E9000 FLUTED LOW SPEED OPTIMUM BUR,ROUND, WAS BEING USED DURING A TYMPANOPLASTY PROCEDURE ON 13OCT22 WHEN IT WAS REPORTED, ¿BROKE 30 SECONDS INTO THE CASE. (HEAD OF BUR BROKE FROM SHAFT).¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. FURTHER ASSESSMENT QUESTIONS FOUND THAT THE DEVICE COMPONENT FELL INTO THE PATIENT AND WAS RETRIEVED WITH A HEMOSTAT. THERE WAS NO REPORT OF DELAY TO THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS LISTED AS ¿PATIENT AT HOME RECOVERING¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726174 ↗