N/A 3127655Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000035853), received between Aug 11, 2023 and Nov 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AN EAR DRILL WAS USED TO GRIND THE MASTOID PROCESS OF THE TEMPORAL BONE, AND THE DRILL BIT BROKE AND THE FRAGMENTS DID NOT FALL INTO THE BODY BUT FELL ON THE OPERATING TABLE OR THE GROUND AND A SMALL PART OF THE FRAGMENTS WERE DIRECTLY SUCKED AWAY BY THE NEGATIVE PRESSURE SUCTION DEVICE. INTERVENTION PERFORMED HAS BEEN PERFORMED. THERE WAS A PROCEDURE DELAY BUT THE EXTENDED TIME WAS UNCERTAIN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788354 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING OTOLOGY SURGERY, THE BUR SUDDENLY BROKE INTO THREE PIECES WHILE USING, AND THE MIDDLE BROKEN PART FLEW OUT, CUTTING THE VISAO COOLING PIPE. THE TIP END FELL INTO THE PATIENT'S EAR AND THEN TOOK IT OUT. THERE WAS A DELAY OF 15 MINS, PROCEDURE COMPLETED WITH BACKUP PRODUCT AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17506812 ↗