NA M006864540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729894964), received between Jul 22, 2019 and Oct 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THIS FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295838 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2019 THAT A LIGHTTRAIL 600UM SINGLE LASER FIBER WAS USED IN A CYSTOSCOPY WITH BLADDER STONE LITHOTRIPSY WITH LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE DURING LASER FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL 600UM SINGLE USE LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811627 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A LIGHTTRAIL 600UM SINGLE LASER FIBER WAS USED IN A CYSTOSCOPY WITH BLADDER STONE LITHOTRIPSY WITH LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE DURING LASER FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL 600UM SINGLE USE LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811626 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2019 THAT A LIGHTTRAIL 600UM SINGLE LASER FIBER WAS USED IN A CYSTOSCOPY WITH BLADDER STONE LITHOTRIPSY WITH LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE DURING LASER FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL 600UM SINGLE USE LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811601 ↗