SOLTIVE TFL-FBX150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00821925043886), received between Aug 5, 2022 and Sep 23, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  The customer returned the Single Use Fiber to the service center for a separate issue. During the device analysis, the investigator indicates that the fiber was broken/damaged, likely due to stress or handling. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871350 ↗
• MalfunctionAug 28, 2026Fracture

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498647 ↗
• MalfunctionJun 5, 2026Material Twisted/Bent

  THE CUSTOMER RETURNED THE POWERED LASER SURGICAL INSTRUMENT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT A FIBER IS KINKED AT SEVERAL TIMES WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411606 ↗
• MalfunctionMay 18, 2026Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25206901 ↗
• MalfunctionApr 20, 2026Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT TWO PORTIONS OF THE SINGLE USE FIBER WERE HEAVILY DAMAGED AND THE FIBER WAS DETACHED NEAR THE PLUG. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931364 ↗
• MalfunctionFeb 10, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307486 ↗
• MalfunctionDec 18, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837772 ↗
• MalfunctionDec 10, 2025Break; Break

  NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771458 ↗
• MalfunctionDec 10, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771449 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THE 150 MICRON TFL SINGLE USE FIBER WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC RETROGRADE INTRARENAL SURGERY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744211 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT FIBER WAS BROKEN, AND FELT IT HAD A FEW BUMPS IN THE JACKET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692719 ↗
• MalfunctionNov 24, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631948 ↗
• MalfunctionAug 14, 2025Melted; Melted

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809661 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THE 150 MICRON TFL SINGLE USE FIBER HAD THE FIBER OPENING ALREADY CUT. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629442 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE LASER FIBER OF THE POWERED LASER SURGICAL INSTRUMENT BROKE DURING A KIDNEY STONE LASER TREATMENT AND APPEARED BURNED AT BOTH ENDS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372798 ↗
• MalfunctionJun 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE 150 MICRON TFL SINGLE USE FIBER 'S ATTACHMENT END WAS BENT AT A 90 DEGREE ANGLE. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150343 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER WAS ALREADY BROKEN WHEN UNPACKING IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908371 ↗
• MalfunctionJan 3, 2025Fire; Fire

  IT WAS REPORTED THE 150 MICRON TFL SINGLE USE FIBER HAD A FIRE BREAK OUT BETWEEN THE SHEATH OF THE LASER FIBER AND THE CONNECT AFTER ACTIVATION OF THE LASER. THIS MALFUNCTION OCCURRED DURING A THERAPEUTIC FLEXIBLE URS (URETERORENOSCOPY) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066979 ↗
• MalfunctionAug 30, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE FIBER BROKE. THE REPORTED PROBLEM WAS FOUND DURING AN UNSPECIFIED KIDNEY PROCEDURE. THE FIBER BROKE INSIDE THE URETEROSCOPES' SHEATH. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321433 ↗
• MalfunctionAug 23, 2022Break; Break

  THE CUSTOMER REPORTED ERROR 447 OCCURRED WITH THE SINGLE-USE FIBER. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING EVALUATION, A BREAK WAS FOUND NEAR THE MIDDLE OF THE FIBER BODY. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (FIBER BREAK). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275987 ↗
• MalfunctionAug 5, 2022Material Split, Cut or Torn; Unintended Electrical Shock; Material Split, Cut or Torn; Unintended Electrical Shock

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC RIGID URETEROSCOPY WITH LITHOTRIPSY, A REGISTRAR WAS USING THE SOLTIVE SUPERPULSED LASER TO TREAT A URETERIC STONE WITH A SEMI-RIGID URETEROSCOPE. DURING THE CASE, THE SCRUB NURSE WAS HOLDING THE 150 MICRON TFL SINGLE USE FIBER WHILE THE LASER WAS EMITTING. THE SCRUB NURSE WITNESSED A FLASH THROUGH THE LASER FIBER AND ALSO GOT A MINOR SHOCK (OR LASER EMISSION THAT FELT LIKE A SHOCK). UPON LOOKING BACK AT THE FIBER, THE FIBER HAD SPLIT FROM THE PLUG. THE SCRUB NURSE DID NOT HAVE ANY INJURY AS A RESULT OF THE SHOCK. THERE WAS NO INJURY TO THE PATIENT OR ANYONE ELSE. THERE WAS NO ERROR MESSAGE RELATING TO THE FIBER SPLIT. THE TEAM OPENED ANOTHER 150 MICRON TFL SINGLE USE FIBER OF A DIFFERENT LOT NUMBER. THE FIBER DID NOT OPEN THE DUST COVER. THE STONE WAS SMALL AT THIS STAGE AND THE REGISTRAR WAS ABLE TO REMOVE THE STONE USING A BASKET. AS A TEST, THE CUSTOMER HAD TAKEN AN UNOPENED FIBER FROM THE SAME LOT NUMBER AND HAD SUCCESSFULLY OPENED THE DUST COVER. UPON LOOKING BACK AT THE EVENT LOG OF THE LASER, THE CUSTOMER HAD STATED AN ERROR 51 MESSAGE OCCURRED ("MAKE SURE THAT NO OBJECTS ARE BLOCKING DUST S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179158 ↗

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