N/A 8450012040DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327096859), received between Jun 24, 2019 and Jul 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907838 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876605 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  THE USER FACILITY SENT THE DEVICE TO THE MANUFACTURER FOR SERVICE EVALUATION. A STUCK AND FRACTURED CUTTING ACCESSORY WAS OBSERVED IN THE DEVICE UPON INITIAL RECEIPT AT THE MANUFACTURER FACILITY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082745 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON THE PATIENTS NOSE, THE BUR OVERHEATED AND BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES OR DELAY AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727331 ↗