E9000 E8150LSORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854011713), received between Jun 1, 2022 and Jun 1, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER ON 19MAY2022 THE DEVICE, E8150LSO, 5 X 38MM E9000 FLUTED LOW SPEED OPTIMUM B WAS BEING USED WHEN IT WAS REPORTED THAT ¿THE BUR IS BROKEN DURING THE SURGERY¿. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT "YES, THE BUR BROKE DURING THE SURGERY: THE SURGEON WAS PERFORMING A MASTOIDECTOMY AND, WHEN HE STARTED USING THE 5MM BUR, IT MET A KIND OF BONE ¿STEP¿, WHOSE IMPINGEMENT CAUSED THE BUR RUPTURE." THE SPHERICAL TIP OF THE BURR WAS FRAGMENTED AND RETRIEVED USING A FORCEP. THE PROCEDURE WAS COMPLETED WITH A ONE OR TWO MINUTE DELAY. IT WAS ALSO FOUND THAT ¿THE PATIENT WASN¿T AFFECTED BY THE INCIDENT¿ AND NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. 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 14567576 ↗