SOLTIVE TFL-FBX150BSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00821925043923), received between May 18, 2022 and Sep 14, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Sparking

  It was reported that the single use fiber was broken by the end that plugs into the Soltive System. The user fired the Laser System without aiming beam present and a small flame was observed and was subsequently extinguished by the scrub nurse. The issue occurred at the beginning of the laser lithotripsy procedure that was completed with a similar device. There was no patient or user harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751630 ↗
• MalfunctionJun 25, 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 25621089 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT DURING AN URETEROSCOPY, THE SINGLE USE FIBER BROKE AT THE CONNECTION POINT TO THE LASER GENERATOR. THE USER USED A BACKUP DEVICE TO CONTINUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233408 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, THE 150MICRONS LASER FIBER BROKE AT THE SITE OF INSERTION TO THE INSTRUMENT CHANNEL OF THE SCOPE AFTER IT FIRED. THE USER OPENED A NEW 200MICRONS LASER FIBER AND PROCEDURE COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743774 ↗
• MalfunctionFeb 27, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471150 ↗
• MalfunctionFeb 25, 2026Fire

  IT WAS REPORTED THE MICRON TFL BALL TIP SINGLE USE FIBER EXHIBITED THE LASER FIBER FAILED, AND IT LOOKED LIKE IT WAS ON FIRE. SPARKS AND FIRE COMING OUT OF THE TIP OF THE FIBER CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 24447196 ↗
• MalfunctionFeb 24, 2026Break; Contamination

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434961 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC RETROGRADE INTRARENAL SURGERY, THE SINGLE USE FIBER WAS OPENED AND THE BEAM WAS OBSERVED EMITTING FROM THE MID-SECTION OF THE FIBER. A SECOND FIBER FROM THE SAME LOT NUMBER WAS OPENED AND THE SAME ISSUE PERSISTED. A THIRD FIBER WAS THEN OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS FIBER. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 2 OF 2 FOR THE SECOND FIBER USED DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214945 ↗
• MalfunctionDec 15, 2025Flare or Flash; Flare or Flash

  NO NEW ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812096 ↗
• MalfunctionNov 24, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639816 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE BROKE BETWEEN THE LASER SYSTEM AND THE SCOPE -OUTSIDE THE SCOPE AND OUTSIDE THE PATIENT. THE ISSUE WAS OBSERVED DURING AN URETEROSCOPY WITH LASER LITHOTRIPSY, AFTER LASERING THE STONE SUCCESSFULLY FOR APPROXIMATELY 5 MINUTES, AND COMPLETED WITH A SIMILAR DEVICE. A SMALL MARK WAS REPORTED ON THE USER¿S FINGER WHEN THE USER CAME IN CONTACT WITH THE ACTIVE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405734 ↗
• MalfunctionMay 14, 2025Flare or Flash; Flare or Flash

  IT WAS REPORTED DURING A THERAPEUTIC URETEROSCOPY LASER PROCEDURE, A NURSE MOVED IN FRONT OF THE LASER, CRACKING THE BLUE LASER FIBER CLADDING AT THE HUB CONNECTION POINT. ACCORDING TO THE INITIAL REPORTER, THE CASE CONTINUED WITHOUT KNOWLEDGE OF THIS EVENT UNTIL THE STAFF BEGAN TO SMELL SMOKE. REPORTEDLY, THE NURSE STANDING DIRECTLY IN FRONT OF THE LASER FIBER CONNECTION WAS LASERED THROUGH THEIR LEAD VEST AND ONTO THEIR BACK. UPON DISCOVERING THIS FAILURE, THE LASER WAS QUICKLY STOPPED, AND ANOTHER LIKE-UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021628 ↗
• MalfunctionMar 21, 2025Sparking; Sparking

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664896 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED, THE 150 MICRON TFL BALL TIP SINGLE USE FIBER TIP BROKE OFF. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED, AFTER A 2 MINUTE DELAY, WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385832 ↗
• MalfunctionMay 15, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE-USE FIBER BROKE FROM CONNECTION TO THE LASER SYSTEM AND CAUGHT FIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC (CYSTOURETHROSCOPY W/URETEROSCOPY/PYELOSCOPY W/LITHOTRIPSY INCL STENT INSERTION) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320516 ↗
• MalfunctionDec 16, 2022Fire; Fire

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE 150 MICRON TFL BALL TIP SINGLE USE FIBER CAUGHT ON FIRE. THE FACILITY REPORTED THAT THE DISPOSABLE FIBER THAT PLUGS INTO THE WALL HAD 5CM OF PLASTIC BEFORE IT, AND THE PLASTIC CAUGHT FIRE ON THE SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM. IT WAS REPORTED THAT THE FIRE OCCURRED RIGHT AFTER THE MACHINE WAS ACTIVATED VIA FOOTSWITCH. THE UNIT WAS QUICKLY TURNED OFF FROM THE WALL AND THE FIRE WAS PUT OUT WITH THE TOWEL WHICH SMOTHERED THE FLAMES. THE CUSTOMER REPORTED THE FIRE WAS COMING OUT OF THE LASER UNIT WHERE THE FIBER CONNECTS. THE ISSUE OCCURRED DURING A RENAL STONE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE WITH APPROXIMATELY FIFTEEN MINUTES DELAY DUE TO THE INCIDENT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) OLTIVE PREMIUM SUPERPULSED LASER SYSTEM)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000382 ↗
• MalfunctionSep 13, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS REMOVED FROM THE SHEATH AND PLUGGED IN THE LASER WHEN THEY NOTICED THE LASER FIBER WAS BROKEN AT THE CONNECTOR END. THE CONNECTOR WAS SECURED TO THE SHEATH CLIP WHEN IT WAS IN THE POUCH. THERE WAS RESISTANCE WHEN REMOVING THE FIBER CONNECTOR FROM THE SHEATH CLIP. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411536 ↗
• MalfunctionMay 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A FAILURE OCCURRED WITH THE 150 MICRON TFL BALL TIP SINGLE USE FIBER. THE FIBER WAS CONNECTED IN THE STANDARD FASHION TO THE SOLTIVE AT A SETTING OF 0.2J AND100HZ. A SHORT PULSE DURATION WAS SELECTED AND IMMEDIATELY UPON HITTING THE PEDAL FOR THE FIRST TIME, THERE WAS A NOISE FROM THE CONNECTOR. THE FIBER OPTIC PART OF THE FIBER WAS DETACHED FROM THE CONNECTOR AND THE VERY END OF THE CONNECTOR IGNITED WITH A SMALL FLAME. THE CUSTOMER INSTANTLY RECOGNIZED THE ABNORMAL SOUND AND PUT A WET TOWEL OVER THE CONNECTOR THAT EXTINGUISHED THE FLAME. AFTERWARDS, THE CONNECTOR WAS REMOVED FROM THE FIBER. THE EVENT OCCURRED DURING PREPARATION FOR USE AND A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431532 ↗

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-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