SOLTIVE TFL-FBX200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00821925043947), received between Apr 20, 2022 and Sep 25, 2026 — classified as 5 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Break” (55 reports).

3 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 ↗

3. May 26, 2022Terminated

   Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

   Z-1296-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break; Fire

  The customer reported that a Single Use Fiber broke and generated a small fire upon insertion into the laser port of the Powered Laser Surgical Instrument during a therapeutic ureteroscopy with laser lithotripsy procedure. The event occurred while the patient was sedated, and the device was in use. The fire was extinguished promptly, and no injury or burn to the patient was reported. At the time of the event, no flammable materials, anesthetic agents, or high concentrations of oxygen were being used in the immediate surgical area. The laser equipment was positioned more than five feet away from the patient, and because the patient was intubated, oxygen and anesthetic gases were not present at the surgical site. The procedure was completed using a competitor's laser unit and laser fiber. The patient's outcome was reported as no injuries noted, and no adverse outcome was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898371 ↗
• MalfunctionSep 21, 2026Fire

  The customer reported laser fiber caught fire during procedure during an unspecified procedure involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50842255 ↗
• MalfunctionSep 21, 2026Fire

  The customer reported Laser fiber was damaged during a therapeutic laser case involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841662 ↗
• MalfunctionSep 9, 2026Fire; Sparking

  The customer reported that the laser fiber caught fire displayed during a therapeutic unspecified procedure involving an Olympus fiber. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701665 ↗
• MalfunctionJun 22, 2026Material Split, Cut or Torn

  THE CUSTOMER RETURNED THE POWERED LASER SURGICAL INSTRUMENT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TEAM INDICATED THAT THE BLUE SHEATH FROM THE TIP OF THE FIBER WAS TORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577503 ↗
• MalfunctionJun 8, 2026Fire

  THE CUSTOMER REPORTED A FIRE DURING A THERAPEUTIC LITHOTRIPSY PROCEDURE INVOLVING AN OLYMPUS POWERED LASER SURGICAL INSTRUMENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428324 ↗
• MalfunctionJun 5, 2026Degraded; Melted

  THE CUSTOMER RETURNED THE SINGLE USE FIBER TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE DEVICE TIP WAS DAMAGED, AND THE BLUE INSULATION IS MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414243 ↗
• MalfunctionMay 8, 2026Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE FIBER EXHIBITED CHARRED MARKS OBSERVED ON THE FRACTURED END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128909 ↗
• MalfunctionMay 6, 2026Break; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE FIBER DISTAL TIP HAD BROKEN OFF AND THE INSULATION NEAR THE DISTAL TIP APPEARED TO HAVE WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25103851 ↗
• MalfunctionApr 20, 2026Degraded; Optical Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE FIBER WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927349 ↗
• MalfunctionApr 20, 2026Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE FIBER TIP WAS CHIPPED OFF AT ABOUT 1.5MM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926512 ↗
• MalfunctionApr 20, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT HAD BREAKAGE ON THE BLUE SHEATH AND FIBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924333 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT LASER FIBER BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC LASER LITHOTRIPSY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905201 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THE SINGLE USE FIBER TIP BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315080 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THE SINGLE-USE FIBER BROKE DURING USE IN A THERAPEUTIC URETEROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024469 ↗
• MalfunctionJan 2, 2026Material Disintegration; Fracture; Detachment of Device or Device Component

  DURING AN UNSPECIFIED PROCEDURE INVOLVING LASER USE TO MANIPULATE A STONE, THE LASER FIBER FRACTURED WHILE INSIDE THE PATIENT. A SMALL REMNANT OF THE FRACTURED FIBER BROKE OFF AND REMAINED IN THE PATIENT. THE REMNANT WAS SUBSEQUENTLY RETRIEVED USING A RETRIEVAL BASKET. NO FURTHER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942146 ↗
• MalfunctionDec 16, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816055 ↗
• MalfunctionDec 15, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23803460 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTRODES, PROBES EXHIBITED THAT THE LASER FIBER WAS BROKEN UPON UNPACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500794 ↗
• MalfunctionOct 30, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429289 ↗
• InjurySep 5, 2025Break; Energy Output Problem; Break; Energy Output Problem

  IT WAS REPORTED THAT AT THE END OF A THERAPEUTIC URETER LITHOTRIPSY AND RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, THE LASER BROKE DOWN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A 30 MINUTES DELAY TO SEARCH FOR ANY POTENTIAL FIBER DEBRIS IN THE PATIENT, BUT NONE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984240 ↗
• MalfunctionAug 29, 2025Fracture; Fracture

  IT WAS REPORTED THE LASER FIBER (SUBJECT DEVICE) BROKE IN HALF, ABOUT NINE INCHES PROXIMALLY FROM THE TIP. THE USER ATTEMPTED TO USE ANOTHER LASER FIBER, HOWEVER THE SOLTIVE LASER SYSTEM NO LONGER TURNED ON/POWERED ON. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926542 ↗
• MalfunctionAug 27, 2025Optical Problem; Optical Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 22903334 ↗
• MalfunctionAug 26, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896343 ↗
• MalfunctionAug 21, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 22862629 ↗

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-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-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-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-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-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