Oto-Flex 3155648Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000036089), received between Jan 31, 2025 and Jul 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Vibration” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Vibration; Material Twisted/Bent; Vibration; Material Twisted/Bent

  IT WAS REPORTED THAT PREOPERATIVELY, NEW BUR FOUND WOBBLING AND SLIGHTLY BENT. BENT WAS OBSERVED AS SOON AS IT WAS REMOVED FROM THE PACKAGE. THERE WAS NO DAMAGE TO THE OUTER PACKAGE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491386 ↗
• MalfunctionJun 21, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, SKEETER BURR WAS WOBBLING. HANDPIECE WAS NOT CAUSING THE BUR TO WOBBLE AND BUR WAS NOT WORKING FINE WITH OTHER HANDPIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303695 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, DURING PRE-OP WHEN THE BUR WAS PLACED IN THE SKEETER AND THE PEDAL WAS PRESSED AT ANY RPM, THE CUTTER WOBBLES VERY LITTLE, ALMOST IMPERCEPTIBLY. THE PROCEDURE WAS DELAYED BY ONE HOUR. THE PROCEDURE WAS COMPLETED WITH OTHER OPERATING TECHNIQUES (MANUAL OR VISAO). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280750 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, DURING PRE-OP WHEN THE BUR WAS PLACED IN THE SKEETER AND THE PEDAL WAS PRESSED AT ANY RPM, THE CUTTER WOBBLES VERY LITTLE, ALMOST IMPERCEPTIBLY. THE PROCEDURE WAS DELAYED BY ONE HOUR. THE PROCEDURE WAS COMPLETED WITH OTHER OPERATING TECHNIQUES (MANUAL OR VISAO). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280705 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, DURING PRE-OP WHEN THE BUR WAS PLACED IN THE SKEETER AND THE PEDAL WAS PRESSED AT ANY RPM, THE CUTTER WOBBLES VERY LITTLE, ALMOST IMPERCEPTIBLY. THE PROCEDURE WAS DELAYED BY ONE HOUR. THE PROCEDURE WAS COMPLETED WITH OTHER OPERATING TECHNIQUES (MANUAL OR VISAO). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280657 ↗