EndoStat 0010-6122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953000053), received between Nov 8, 2017 and Jul 31, 2018 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE THE SURGEON WAS LASERING THE PATIENT'S EAR; THE END OF THE FIBER BURNT OFF AND BECAME DETACHED. THE SURGEON CONFIRMED THAT THE DETACHED FRAGMENT HAD NOT REMAINED IN THE PATIENT¿S EAR BY LOOKING THROUGH THE MICROSCOPE AND A 30-DEGREE SCOPE. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7734935 ↗
• MalfunctionNov 8, 2017Break; Detachment Of Device Component; Temperature Problem; Break; Detachment Of Device Component; Temperature Problem

  IT WAS REPORTED THAT DURING STAPEDOTOMY PROCEDURE AIM BEAM WAS TESTED AND NO AIM BEAM PRESENT AT THE END OF THE FIBER WAS OBSERVED. THE FIBER WAS EXCHANGED AND SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT AFTER THE PROCEDURE THE HOSPITAL TECHNICIAN TRIED THE FIBER ONCE MORE AND LASER SHOT STRAIGHT THROUGH THE FIBER. PATIENT OUTCOME: NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7009647 ↗