LightTrail™ Single Use M0068F64560Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729939795), received between Mar 7, 2018 and Jun 18, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 29, 2020 THAT A LIGHTTRAIL SINGLE USE 800UM LASER FIBER WAS USED IN A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER SPLIT AT THE WORKING END. THE PHYSICIAN THEN TRIMMED THE WORKING END PART OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL LIGHTTRAIL SINGLE USE 800UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171236 ↗
• MalfunctionMar 7, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-00653 AND 3005099803-2018-00654 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 13, 2018 THAT A LIGHTTRAIL 800UM SINGLE USE LASER FIBER AND LIGHTTRAIL 600UM SINGLE USE LASER FIBER WERE USED IN A THULIUM LASER ABLATION OF THE PROSTATE PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTED THAT THE FIBER TIP BROKE OFF UPON INSERTION INTO THE CYSTOSCOPE (CAPTURED IN MFR. # 3005099803-2018-00653). A SECOND LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS OPENED AND THE SAME THING HAPPENED (CAPTURED IN MFR. # 3005099803-2018-00654). REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THE SECOND LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321393 ↗