OtoLase™ FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290109141862), received between Aug 23, 2023 and Jun 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIBER WAS RETURN TO BOSTON SCIENTIFIC WITHOUT PERFORMANCE ALLEGATION DESCRIPTION. UPON COMPLETION OF THE FIBER ANALYSIS, IT WAS IDENTIFIED THAT FIBER TIP WAS BROKEN. THEREFORE, BASED ON THIS SPECIFIC ANALYSIS FINDING, REPORTABILITY CRITERIA IS MET. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191455 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING A STAPEDECTOMY SURGERY, THE FIBER BURNT OUT AND BROKE IN THE MIDDLE CREATING FIRE. LASER WAS IN DEFAULT SETTING WITH POWER 10 W. THE CONSOLE SEEMED TO BE WORKING FINE. THE PHYSICIAN IMMEDIATELY CHANGED THE LASER. LATER THE PROCEDURE WAS COMPLETED USING A NON-FIBER MODE (FREE HAND) WITH A MICROMANIPULATOR. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031891 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BURNT AND BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981385 ↗
• MalfunctionMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FIBER WAS RETURNED WITH NO ALLEGATION. ANALYSIS OF THE RETURN DEVICE IDENTIFIED THAT THE FIBER TIP WAS BROKEN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606393 ↗
• MalfunctionOct 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE, THE POWER WAS NOT HIGH ENOUGH TO COMPLETE THE PROCEDURE. IT WAS FOUND THAT THE ISSUE WAS WITH THE FIBER. FIBER TIPS WERE REPLACED BUT THE ISSUE CONTINUED. DIFFERENT CONNECTIONS AND SETTING WERE ATTEMPTED BUT IT DID NOT WORK. THERE WERE NO OTHER FIBERS AVAILABLE, AND THE PROCEDURE WAS CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423283 ↗
• MalfunctionJun 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE THE FIBER WAS FIRED TWICE, HOWEVER, LIGHT WAS NOT EMITTED FROM THE END OF THE FIBER. THE FIBER WAS TRIED ON TWO DIFFERENT LASER CONSOLES BUT WAS NOT TRIED ON THE PATIENT. THE FIBER WAS REPLACED TO COMPLETE THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629643 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING REMOVAL ATTEMPTS OF THREE FIBERS, THEY GOT STUCK AND SUBSEQUENTLY BROKE INSIDE THE HANDPIECES, DAMAGING BOTH THE FIBERS AND THE HANDPIECES AND RENDERING THEM UNUSABLE. A THOROUGH INSPECTION OF THE LASER EQUIPMENT AND ALIGNMENT OF THE DUO SYSTEM SHOWS NO ISSUES. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR FIBER 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272424 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING REMOVAL ATTEMPTS OF THREE FIBERS, THEY GOT STUCK AND SUBSEQUENTLY BROKE INSIDE THE HANDPIECES, DAMAGING BOTH THE FIBERS AND THE HANDPIECES AND RENDERING THEM UNUSABLE. A THOROUGH INSPECTION OF THE LASER EQUIPMENT AND ALIGNMENT OF THE DUO SYSTEM SHOWS NO ISSUES. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR FIBER 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272421 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING REMOVAL ATTEMPTS OF THREE FIBERS, THEY GOT STUCK AND SUBSEQUENTLY BROKE INSIDE THE HANDPIECES, DAMAGING BOTH THE FIBERS AND THE HANDPIECES AND RENDERING THEM UNUSABLE. A THOROUGH INSPECTION OF THE LASER EQUIPMENT AND ALIGNMENT OF THE DUO SYSTEM SHOWS NO ISSUES. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR FIBER 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272414 ↗
• MalfunctionAug 23, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE FIBER WAS STUCK ON THE DEVICE AND THE AIMING BEAM WAS NOT PRESENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608577 ↗