NA M006864640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729894995), received between Aug 3, 2018 and Mar 17, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Break; Misfire; Material Integrity Problem; Break; Misfire; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 25, 2020 THAT A LIGHTTRAIL SINGLE USE 270UM LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCOPE WAS NOTED TO BE BROKEN AFTER LASER USE. THE SCOPE WAS TESTED AND A LEAK WAS IDENTIFIED ON THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9843213 ↗
• MalfunctionFeb 25, 2020Break; Misfire; Optical Problem; Break; Misfire; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 07, 2020 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER SETTINGS WERE 0.5 JOULES AND 5 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AIMING BEAM OF THE LASER FIBER WAS NOT WORKING. THE LASER UNIT MADE A FEW CRACKLING SOUNDS AND THE NURSE NOTICED A SPARK COMING OUT FROM THE FIBER CONNECTION AREA. THE PROCEDURE WAS COMPLETED WITH GRASPER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750671 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 16, 2018 THAT A LIGHTTRAIL 270UM SINGLE USE LASER FIBER WAS OPENED FOR USE IN A FLEXIBLE URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE LASER BODY BROKE UPON REMOVAL FROM THE PACKAGE. REPORTEDLY, THERE WAS NO DAMAGE NOTED TO THE PACKAGE OR DEVICE PRIOR TO OPENING THE PRODUCT POUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER LASER FIBER. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156292 ↗
• InjuryAug 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A LIGHTTRAIL SINGLE USE 270M LASER FIBER WAS USED DURING A PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. REPORTEDLY, THE OPERATOR OF THE DEVICE TRIED TO RETRIEVED THE DETACHED TIP BUT IT WAS UNSUCCESSFUL. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748240 ↗