N/A 8450107035DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327097078), received between Mar 8, 2018 and Apr 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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.

• MalfunctionApr 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HEATED UP DURING AN ENDOSCOPIC ENDONASAL CASE, RESULTING IN A MINOR FIRST DEGREE BURN TO THE INSIDE OF THE PATIENT'S NOSTRIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16817924 ↗
• MalfunctionApr 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THAT DEVICE HEATED UP WHICH RESULTED IN A MINOR BURN TO THE PATIENT¿S NOSTRIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16817923 ↗
• MalfunctionFeb 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745660 ↗
• MalfunctionMar 8, 2018Break; Break

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7323234 ↗