SOLTIVE TFL-FBX365SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00821925044005), received between Aug 30, 2022 and Apr 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K242191); they may or may not involve this specific model.

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.

Recalls naming this device

1. May 6, 2025Open, Classified

   Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

   Z-1922-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 1, 2023Open, Classified

   Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

   Z-0748-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT'S FIBER BROKE. THE ISSUE OCCURRED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038314 ↗
• MalfunctionApr 20, 2026Degraded

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TIP ON THE SINGLE USE FIBER WAS WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924273 ↗
• MalfunctionJul 15, 2025Fracture; Fracture

  IT WAS REPORTED DURING A BLADDER STONE LITHOTRIPSY PROCEDURE UTILIZING A RIGID LASER CYSTOSCOPE, THE SURGEON NOTED THE ABSENCE OF AN AIMING BEAM UPON INSERTION OF THE LASER FIBER INTO THE PATIENT. THE FIBER WAS SUBSEQUENTLY WITHDRAWN FOR INSPECTION, REVEALING A FRACTURED TIP AND ADDITIONAL DAMAGE APPROXIMATELY ONE FOOT PROXIMAL TO THE DISTAL END. THE COMPROMISED FIBER WAS REPLACED WITH A NEW ONE BEFORE PROCEEDING WITH THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506029 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE TIP BROKE UPON SCOPE INTRODUCTION. TWO FAILED CONSECUTIVELY FROM THE SAME BOX. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183268 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT TIP BROKE UPON SCOPE INTRODUCTION. TWO FAILED CONSECUTIVELY FROM THE SAME BOX. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167013 ↗
• MalfunctionNov 7, 2024Break; Break

  DURING THE DEVICE EVALUATION, THE SINGLE USE FIBER WAS BROKEN IN HALF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636005 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THE SINGLE USE FIBER HAD THE GLASS TIP COME OFF. THE EVENT OCCURRED DURING A BLADDER STONES REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235545 ↗
• MalfunctionSep 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ELECTRODE'S SOLTIVE FIBER WAS DAMAGED. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THIS ISSUE CAUSED A DELAY AND THE PATIENT WAS NOT IMPACT BY THE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138561 ↗
• MalfunctionSep 7, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT FOUR FIBERS BROKE DURING A UROSCOPY. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. TWO OF THE THREE WERE BROKE DURING THE INSERTION INTO THE ENDOSCOPE. RELATED COMPLAINTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371738 ↗
• MalfunctionSep 7, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT FOUR FIBERS BROKE DURING A UROSCOPY. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. TWO OF THE THREE WERE BROKE DURING THE INSERTION INTO THE ENDOSCOPE. RELATED COMPLAINTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371390 ↗
• MalfunctionAug 30, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE FIBER BROKE ABOUT A FOOT FROM THE DISTAL END OF THE FIBER. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR A THERAPEUTIC CYSTOLITHOLAPAXY. THE PART OF THE FIBER BREAKAGE POINT WAS INSIDE THE SCOPE AND IT DIDN'T BREAK IN THE PATIENT'S BLADDER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320749 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242191. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2026 · Feb 27, 2026 · Open, Classified
  Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Descriptio
• Z-1695-2026 · Feb 27, 2026 · Open, Classified
  Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An el
• Z-1921-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A P
• Z-1920-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIV
• Z-1923-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL
• Z-1715-2025 · Apr 4, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems