EndoStat 0010-0622Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00878953000107), received between Mar 30, 2018 and Aug 24, 2020 — classified as 9 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN NOTICED THE TIP FLARE FROM THE FIBER WAS POOR. THE PERFORMANCE WAS POOR BUT ENOUGH TO COMPLETE THE CASE WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. THE FIBER WAS RETURNED AND ANALYSIS FOUND THAT THE DISTAL END OF THE GLASS FIBER WAS FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445634 ↗
• MalfunctionJan 15, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE FIBER CONNECTOR DETACHED FROM THE FIBER AND AIM BEAM IS VISIBLE AT CONNECTOR OPENING. THERE WAS NO PATIENT OR USER IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251439 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE PROCEDURE COMPLETED IT WAS NOTICED THAT THE TIP OF THE FIBER WAS MISSING. MANY ATTEMPTS TO FIND AND REMOVE THE TIP WAS UNSUCCESSFUL. THE LENGTH OF THE TIP WAS 3MMLONG AND 0.4MM IN DIAMETER. THE AREA WAS CAREFULLY INSPECTED AND THE MISSING TIP WAS NOT FOUND. IT IS BEING ASSUMED THAT IT WAS SWALLOWED AND WOULD BE PASSED OUT. IT WAS ALSO REPORTED THAT THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7904007 ↗
• MalfunctionAug 28, 2018Fracture; Fracture

  ANALYSIS OF THE RETURN DEVICE REVEALED A FRACTURE ON THE DISTAL TIP OF THE FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824475 ↗
• MalfunctionJun 5, 2018Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING USE OF THE FIBER, THE PHYSICIAN SAW "A FLASH". THE CONSOLED WAS PLACED ON STANDBY BY THE LASER TECHNICIAN AND IT WAS NOTICED THAT THE OUTSIDE OF THE SHEATH HAD MELTED. THE FIBER WAS CLEAVED AND RESTRIPED TO COMPLETE THE CASE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568941 ↗
• MalfunctionMay 22, 2018Break; Break

  ANALYSIS OF THE RETURN DEVICE REVEALED THAT THE FIBER IS BROKEN AND DETACHED FORWARD OF CONNECTOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531592 ↗
• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING AN OHNS PROCEDURE (OTOLARYNGOLOGY/HEAD AND NECK SURGERY), THE FIBER BROKE OFF AT THE BASE. PATIENT OUTCOME: "NOT HARMED" - THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431060 ↗
• MalfunctionMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA FOR A MICROLARYNGOSCOPY PROCEDURE. UPON STARTING THE PROCEDURE, THE FIBER CONNECTOR END PART (*SUBJECT DEVICE) CONNECTING TO THE CONSOLE, BURNT. A SECOND FIBER WAS UTILIZED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN ABORTED THE PROCEDURE AFTER THE SECOND FIBER FAILED. THE PATIENT WAS REPORTED TO BE OKAY. THIS IS THE 1ST OF 2 REPORTS FILED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387167 ↗
• MalfunctionMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA FOR A MICROLARYNGOSCOPY PROCEDURE. UPON STARTING THE PROCEDURE, THE FIBER CONNECTOR END PART CONNECTING TO THE CONSOLE, BURNT. A SECOND FIBER (*SUBJECT DEVICE) WAS UTILIZED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN ABORTED THE PROCEDURE AFTER THE SECOND FIBER FAILED. THE PATIENT WAS REPORTED TO BE OKAY. THIS IS THE 2ND OF 2 REPORTS FILED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387163 ↗