SOLTIVE TFL-SLSRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00821925044135), received between Nov 19, 2021 and Apr 21, 2026 — classified as 10 injuries, 23 malfunctions.

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

6 FDA recall records name this device's identifier, 6 still open.

4 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. Feb 27, 2026Open, Classified

   Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

   Z-1695-2026 · Root cause: Process control · FDA record ↗

2. 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-1920-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Apr 4, 2025Open, Classified

   Preset treatment parameters are not consistently being used in accordance with the IFU.

   Z-1715-2025 · Root cause: Unknown/Undetermined by firm · FDA record ↗

4. Aug 13, 2024Open, Classified

   The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

   Z-0135-2025 · Root cause: Under Investigation by firm · FDA record ↗

5. May 31, 2024Open, Classified

   Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

   Z-2505-2024 · Root cause: Device Design · FDA record ↗

6. Jan 29, 2024Open, Classified

   A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

   Z-1384-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Overheating of Device

  IT WAS OBSERVED DURING DEVICE INSPECTION THAT WHEN THE SOLTIVE PRO LASER SYSTEM WAS POWERED ON, IT POPPED, SPARKED, AND STARTED SMOKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938982 ↗
• MalfunctionFeb 18, 2026Communication or Transmission Problem

  IT WAS REPORTED THE LASER SYSTEM'S WIRELESS PEDAL DID NOT WORK, AS EXHIBITED BY ERROR 139. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380810 ↗
• MalfunctionNov 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594460 ↗
• MalfunctionJul 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS INTERMITTENTLY NOT PAIRING WITH THE WIRELESS FOOT PEDAL. THE BATTERIES WERE REPLACED AND THE FOOT PEDAL PARED WITHOUT ANY FURTHER ISSUES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530191 ↗
• MalfunctionMay 15, 2025Smoking; Smoking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029720 ↗
• MalfunctionApr 23, 2025Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SMELL OF SMOKE WAS OBSERVED TWO TIMES WHILE USING THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894734 ↗
• MalfunctionApr 23, 2025Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SMELL OF SMOKE WAS OBSERVED TWO TIMES WHILE USING THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894650 ↗
• MalfunctionAug 13, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED, THE SOLTIVE PRO SUPERPULSED LASER SYSTEM'S HAND PIECE LASER FIBER CAUGHT FIRE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974267 ↗
• MalfunctionMay 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE LASER SYSTEM HAD ONE PEDAL NOT WORKING ON THE FOOTSWITCH. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19292440 ↗
• MalfunctionMar 12, 2024Disconnection; Disconnection

  IT WAS REPORTED, THE SOLTIVE PRO SUPERPULSED LASER SYSTEM HAD A FOOT PEDAL THAT WAS NOT PAIRING AND CONNECTING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889120 ↗
• MalfunctionFeb 29, 2024Break; Sparking; Break; Sparking

  IT WAS REPORTED, THAT THE LASER SYSTEM HAD BROKE AT THE CONNECTOR FLEXIBLE PART AND SPARKED. THE ISSUE WAS FOUND DURING THE THERAPEUTIC URETHROSCOPY WITH LASER LITHOTRIPSY PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812568 ↗
• MalfunctionJan 5, 2024Fire; Fire

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC LASER LITHOTRIPSY PROCEDURE, THE LASER FIBER CAUGHT ON FIRE AT THE INSERTION POINT OF THE LASER INTO THE MACHINE DURING USE. THE FIRE WAS VISUALIZED, THE OPERATION WAS STOPPED, THE EMERGENCY RED BUTTON ON THE LASER WAS PUSHED, AND THE LASER MACHINE WAS UNPLUGGED FROM THE WALL. THERE WAS NO HARM TO THE PATIENT OR STAFF. NO PATIENT IMPACT, THE SURGERY WAS STOPPED/COMPLETED AT THE TIME OF THE FIRE. THERE WAS NO PROLONGED EPISODE OF CARE AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461048 ↗
• MalfunctionDec 14, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SOLTIVE PRO SUPERPULSED LASER SYSTEM WOULD NOT PAIR WITH THE TFL-AFSWL AND THEY COULD NOT PROPERLY CONFIGURE THE WIRELESS FOOT PEDAL TO THE SYSTEM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327152 ↗
• MalfunctionNov 19, 2023Fire; Fire

  THE CUSTOMER REPORTED TO OLYMPUS, THE SOLTIVE PRO SUPERPULSED LASER SYSTEM CAUGHT FIRE WHERE THE DEVICE PLUGS INTO THE FRONT. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166975 ↗
• MalfunctionNov 7, 2023Fire; Overheating of Device; Fire; Overheating of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE THEY WERE USING THE SOLTIVE PRO SUPERPULSED LASER SYSTEM FOR THE THERAPY, THE TIP CONNECTED TO THE MACHINE CAUGHT FIRE, AND AS A CONSEQUENCE A MEDICAL STAFF SUFFERED MINIMAL HARM. THE LASER WAS STILL INSIDE THE PATIENT, THE GREEN TIP WENT OUT AND A MEDICAL STAFF FELT HEAT, AND WHILE TURNING AROUND THEY NOTICED THAT THE BLUE WIRE WAS MELTED AND THERE WAS A FLAME AT THE END OF THE TIP. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085994 ↗
• MalfunctionOct 13, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO PAIR A WIRELESS FOOTSWITCH TO THIS UNIT. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935328 ↗
• MalfunctionSep 12, 2023Fire; Fire

  THE CUSTOMER REPORTED THE LASER FIBER THAT THIS FIBER CAUGHT ON FIRE AT THE CONNECT ION POINT. THE CUSTOMER PUT THE LASER ON STANDBY AND STOPPED THE FIRE. THERE WERE NO REPORTS OF HARM. THIS EVENT INCLUDES TWO (2) REPORTS . REPORT WITH PATIENT IDENTIFIER (B)(6), LASER SYSTEM MODEL TFL-PLS , SERIAL NUMBER IS NOT KNOWN. REPORT WITH PATIENT IDENTIFIER (B)(6), BALL TIP SINGLE USE FIBER- TFL-FBX200BS, LOT KR262865. THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT (B)(6), LASER SYSTEM MODEL TFL-PLS , SERIAL NUMBER IS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733214 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED TO OLYMPUS THAT SEVERAL PATIENTS WITH URETERAL STENOSIS WERE BEING REFERRED FROM OTHER PHYSICIANS WHO USED THULIUM FIBER LASERS TO TREAT THEIR URETERAL STONES. FURTHERMORE, THE PHYSICIAN MENTIONED THAT ONE REASON MAY BE BECAUSE OTHER PHYSICIANS WERE USING HIGHER FREQUENCY LASER SETTINGS TO TREAT URETERAL STONES. THE PHYSICIAN WAS REFERRING TO ALL LASERS INCLUDING OLYMPUS SOLTIVE PREMIUM AND SOLTIVE PRO. THE NUMBER OF PATIENTS AND SPECIFIC TREATMENTS PROVIDED ARE UNKNOWN. ADDITIONALLY, THE PHYSICIAN HAS A SOLTIVE, AND STATED THAT THAT THE 40 HZ PRESET FOR URETERAL STONE WAS TOO HIGH AND THE PHYSICIAN DID NOT USE IT. ALSO, THE PHYSICIAN SAID THAT ABOVE 20HZ AND POWERS ABOVE 12 WATTS SHOULD NOT BE USED FOR LASER TREATMENTS IN THE URETER. PATIENT IDENTIFIERS: (B)(6) - SOLTIVE PRO SUPERPULSED LASER SYSTEM. (B)(6) - LASER FIBER FOR SOLTIVE PRO. (B)(6) - SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM. (B)(6) - LASER FIBER FOR SOLTIVE PREMIUM. THIS REPORT IS (B)(6).

  Patient problems: Stenosis

  MAUDE report 17027959 ↗
• MalfunctionApr 6, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED DIFFICULTY PAIRING THE FOOTSWITCH WITH THE LASER SYSTEM. THE USER WAS ABLE TO COMPLETE THE PAIRING PRIOR TO CONTACTING OLYMPUS AND WANTED THE DIFFICULTY RECORDED IN CASE IT HAPPENED AGAIN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689207 ↗
• MalfunctionMar 9, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR USE, THE SUBJECT DEVICE HAD DIFFICULTY PAIRING WITH THE WIRELESS FOOTSWITCH. THE INITIAL ATTEMPT TO CONNECT FAILED. CYCLING POWER TO THE DEVICES RESOLVED THE ISSUE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512029 ↗
• MalfunctionFeb 14, 2023Connection Problem; Connection Problem

  OLYMPUS REPRESENTATIVE (REP.) REPORTED AFTER REPLACING THE BATTERIES IN THE TFL-SLS WIRELESS FOOTSWITCH, THE LOW BATTERY MESSAGE STILL DISPLAYED ON THE TFL-SLS. THE REP. WAS TRYING TO PAIR UP THE WIRELESS FOOTSWITCH WITH THE LASER SYSTEM. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (WIRELESS FOOTSWITCH MODEL TFL-AFSWL WITH UNKNOWN SERIAL NUMBER). REPORT WITH PATIENT IDENTIFIER (B)(6) ( LASER SYSTEM TFL-SLS, SERIAL NO. (B)(4)) THIS REPORT IS BEING SUBMITTED FOR REPORT WITH PATIENT IDENTIFIER (B)(6) ( LASER SYSTEM TFL-SLS, SERIAL NO. (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370279 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT A PATIENT DEVELOPED URETHRAL RESTRICTION AFTER A STONE REMOVAL PROCEDURE USING THE SOLTIVE PRO SUPERPULSED LASER SYSTEM. THERE WAS NO REPORTED ISSUE OR INJURY DURING THE PROCEDURE. ADDITIONAL INFORMATION IS BEING REQUESTED TO DETERMINE THE SEVERITY OF THE RESTRICTION AND ITS IMPACT TO THE PATIENT. THE CUSTOMER REPORTED THIS EVENT HAS OCCURRED A TOTAL OF FOUR TIMES WITH FOUR SEPARATE PATIENTS. THESE EVENTS ARE RECORDED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 16218889 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. ABOUT TWO MONTHS AFTER THE STONE REMOVAL PROCEDURE, THE PATIENT UNDERWENT A RIGHT URETEROSCOPY. THE PATIENT WAS THEN REFERRED TO ANOTHER MEDICAL FACILITY, AND ABOUT TWO WEEKS AFTER THE RIGHT URETEROSCOPY, THE PATIENT HAD A NEPHROSTOMY TUBE PLACEMENT DUE TO ACUTE RENAL FAILURE RELATED TO URINARY OBSTRUCTION. AN OLYMPUS REPRESENTATIVE AND THE USER FACILITY ALSO CLARIFIED THAT THIS EVENT OCCURRED ONLY THREE TIMES WITH THREE DIFFERENT PATIENTS AND NOT FOUR AS ORIGINALLY REPORTED. THESE EVENTS ARE RECORDED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - AN OLYMPUS REPRESENTATIVE AND THE USER FACILITY CONFIRMED THAT THERE WERE ONLY THREE PATIENTS AFFECTED. HENCE, THIS REPORT IS NO LONGER REQUIRED.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 16218887 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT A PATIENT DEVELOPED URETHRAL RESTRICTION AFTER A STONE REMOVAL PROCEDURE USING THE SOLTIVE PRO SUPERPULSED LASER SYSTEM. THERE WAS NO REPORTED ISSUE OR INJURY DURING THE PROCEDURE. ADDITIONAL INFORMATION IS BEING REQUESTED TO DETERMINE THE SEVERITY OF THE RESTRICTION AND ITS IMPACT TO THE PATIENT. THE CUSTOMER REPORTED THIS EVENT HAS OCCURRED A TOTAL OF FOUR TIMES WITH FOUR SEPARATE PATIENTS. THESE EVENTS ARE RECORDED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 16218885 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. ABOUT FOUR MONTHS AFTER THE STONE REMOVAL PROCEDURE, THE PATIENT UNDERWENT A RIGHT URETEROSCOPY AND LASER LITHOTRIPSY WITH RIGHT URETEROTOMY. ABOUT TWO MONTHS LATER, THE PATIENT UNDERWENT A RIGHT URETERAL DILATION, AND WAS LATER REFERRED TO ANOTHER MEDICAL FACILITY FOR POSSIBLE URETEROURETEROSTOMY AND URETERAL RECONSTRUCTION. AN OLYMPUS REPRESENTATIVE AND THE USER FACILITY ALSO CLARIFIED THAT THIS EVENT OCCURRED ONLY THREE TIMES WITH THREE DIFFERENT PATIENTS, AND NOT FOUR AS ORIGINALLY REPORTED. THESE EVENTS ARE RECORDED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - AN OLYMPUS REPRESENTATIVE AND THE USER FACILITY CONFIRMED THAT THERE WERE ONLY THREE PATIENTS AFFECTED. HENCE, THIS REPORT IS NO LONGER REQUIRED.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 16218876 ↗

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-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-1922-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200
• 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