SOLTIVE TFL-FBX200BSRecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00821925043985), received between Jun 10, 2022 and Sep 24, 2026 — classified as 3 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (46 reports).

4 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

2. Dec 4, 2023Open, Classified

   Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).

   Z-0718-2024 · Root cause: Under Investigation by firm · FDA record ↗

3. 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 · FDA record ↗

4. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Sparking; Flare or Flash

  It was reported that when the laser of the subject device fired, it sparked and appeared to ignite/burn. There were no reports of patient harm/involvement. During the initial evaluation of the device, the reported event was unable to be confirmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876974 ↗
• MalfunctionSep 22, 2026Material Fragmentation; Sparking

  It was reported that during a therapeutic kidney stone with ureteroscopy and laser lithotripsy, the powered laser surgical instrument sparked at the plug and broke the fiber off of the base while it was inserted inside the laser system. The reported event resulted in a procedural prolongation of less than 30 minutes. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853311 ↗
• MalfunctionSep 2, 2026Break

  No additional information received from the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565723 ↗
• MalfunctionAug 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134084 ↗
• MalfunctionJun 8, 2026Fire

  IT WAS REPORTED THE SINGLE USE FIBER STARTED SPARKING SMOKING STARTING ON FIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430166 ↗
• MalfunctionJun 1, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355773 ↗
• MalfunctionMay 22, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257662 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE SINGLE USE FIBER BROKE DURING AN URETEROSCOPY WITH LASER LITHOTRIPSY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207309 ↗
• MalfunctionMay 6, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096132 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THE SINGLE USE FIBER BROKE WHILE INSERTING IN THE SCOPE. THE ISSUE OCCURRED DURING A THERAPEUTIC LIPOATROPHY 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 25096068 ↗
• MalfunctionApr 20, 2026Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929398 ↗
• MalfunctionApr 16, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE FIBER LASER FIBER WAS IDENTIFIED TO HAVE BREAKAGE AT THE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905045 ↗
• MalfunctionMar 4, 2026Material Fragmentation

  THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY AND LASER FOR KIDNEY STONES PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506219 ↗
• MalfunctionFeb 4, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC STONE LITHOTRIPSY, THE POWERED LASER SURGICAL INSTRUMENT'S LASER FIBER BROKE AND WHEN REMOVING THE LASER FIBER AT THE END OF THE PROCEDURE, THEY NOTICED A 10CM PIECE WAS STILL REMAINED IN THE PATIENT'S URETER WHICH WAS REMOVED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260796 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE SINGLE USE FIBER BROKE AND BURNED THE DOCTORS THUMB DURING A DIAGNOSTIC/THERAPEUTIC CYSTOSCOPY, URETEROSCOPY, AND LASER LITHOTRIPSY. THE PROCEDURE WAS COMPLETED AND NO FOLLOW UP CARE WAS NECESSARY FOR THE BURN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247768 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE SINGLE USE FIBER BROKE INTO TWO PIECES AND MELTED PART OF THE SURGEON'S GOWN DURING A DIAGNOSTIC AND THERAPEUTIC CYSTOSCOPY WITH LITHOTRIPSY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247012 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THE SINGLE UDE FIBER EXHIBITED THE LASER FIBER BROKE FURTHER UP THE FIBER. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190101 ↗
• MalfunctionJan 20, 2026Fire

  IT WAS REPORTED THE SINGLE USE FIBER SOLITIVE SUPER PULSE LASER FIBER CAUGHT ON FIRE WHEN THE LASER FIBER WAS SECURED INTO THE LASER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118046 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT'S LASER FIBER TIP DETACHED. THE ISSUE OCCURRED DURING A URETEROSCOPY WITH CVAC, LASER LITHOTRIPSY, AND STENT EXCHANGE ANDRETROGRADE PYELOGRAMS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095358 ↗
• MalfunctionJan 16, 2026Break; Fire

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT FIBER CAUGHT FIRE WHEN SECURED TO THE LASER. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY WITH LASER ABLATION OF STONE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094987 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT'S FIBER TIP WAS BENT AND LASER LIGHT COMING OUT 1 INCH FROM THE PROXIMAL TIP. THE ISSUE OCCURRED OUT OF BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038473 ↗
• MalfunctionJan 7, 2026

  LASER FIBER BROKE INTO TWO PIECES AND MELTED PART OF THE SURGEON'S GOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988713 ↗
• MalfunctionJan 7, 2026

  LASER WIRE BROKE DURING SURGERY. DR'S LEFT THUMB WAS BURNED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23988693 ↗
• MalfunctionDec 30, 2025Sparking; Sparking

  NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922049 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT BROKE IN TWO PIECES. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877827 ↗

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-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-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-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