SOLTIVE TFL-FBX550SRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00821925044043), received between Apr 5, 2021 and May 29, 2026 — classified as 6 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT THE SINGLE USE FIBER SNAPPED WHILE THE USER WAS PERFORMING A PROSTATE ENUCLEATION. THE DEVICE WAS REPLACED BY A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333124 ↗
• MalfunctionApr 28, 2026Smoking; Sparking

  IT WAS REPORTED THE 550 MICRON TFL SINGLE USE FIBER WAS SMOKING AND HAD SPARKS AT THE PLASTIC HANDLE. THE ISSUE OCCURRED DURING A PROSTATIC ENUCLEATION 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 25016209 ↗
• MalfunctionMar 9, 2026Fire; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548312 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MICRON TFL SINGLE USE FIBER EXHIBITED FIBER TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473740 ↗
• MalfunctionFeb 18, 2026Smoking; Sparking; Flare or Flash

  IT WAS REPORTED THE 550 SOLTIVE SINGLE USE FIBER EMITTED SPARKS AND SMOKE AT THE BASE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROSTATE ENUCLEATION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377219 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THE 550 MICRON TFL SINGLES USE FIBER HAD A BROKEN LASER FIBER IN ITS PROTECTIVE SHEATH. THE ISSUE OCCURRED DURING INSPECTION FOR USE FOR AN UNKNOWN UROLOGICAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. IT WAS REPORTED THE SOLTIVE SUPERPULSED LASER FIBER HAD A BROKEN LASER FIBER IN ITS PROTECTIVE SHEATH. THE ISSUE OCCURRED DURING INSPECTION FOR USE FOR AN UNKNOWN UROLOGICAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986460 ↗
• MalfunctionJul 18, 2025Flare or Flash; Flare or Flash

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED EXCESSIVE FLASH/DAMAGE ON TWO OF THE FIBERS WHILE USING THE SOLTIVE LASER SYSTEM. THE USER WAS ABLE TO COMPLETE THE UNSPECIFIED PROCEDURE USING A THIRD FIBER. THERE WERE NO REPORTS OF PATIENT OR USER HARM. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545714 ↗
• MalfunctionJul 16, 2025Fire; Fire

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521079 ↗
• MalfunctionJun 15, 2025Flare or Flash; Flare or Flash

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED EXCESSIVE FLASH/DAMAGE ON TWO OF THE FIBERS WHILE USING THE SOLTIVE LASER SYSTEM. THE USER WAS ABLE TO COMPLETE THE UNSPECIFIED PROCEDURE USING A THIRD FIBER. THERE WERE NO REPORTS OF PATIENT OR USER HARM. REPORT 1 OF 3. THIS INQUIRY WAS CLONED FROM INQUIRY (INQ-144546/ORIGINAL) BECAUSE MULTIPLE DEVICES WERE REPORTED. THIS INQUIRY (INQ-145210/CLONED) CAPTURES DEVICE 2 OF 2. AUJ/08-JAN-2025. PER UR-350558 THIS IS THE CORRECT EVENT DESCRIPTION: (B)(4), SALES REP, CALLED TO REPORT THE FOLLOWING PHENOMENON. USER REPORTED TO (B)(4) COWORKER WHO REPORTED TO (B)(4) OF THAT THEY EXPERIENCE EXCESSIVE FLASHES ON TWO OF THE FIBERS. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A THIRD FIBER. THEY HAVE ONE UNUSED FROM THIS BOX THAT THEY WANT TO RETURN. I CREATED THE SFDC CASE TO CAPTURE THE REPORTED PHENOMENON AND CONFERENCE THE SALES REP. IN WITH (B)(4) OF UROLOGY SALES SUPPORT FOR ADDITIONAL ASSISTANCE. (B)(4) REPORTED THAT THE FACILITY'S POLICY DICTATES THAT THEY CANNOT RELEASED THE FAILED FIBER TO HIM. RMA NUMBER (B)(4). FG 495722/(B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208569 ↗
• InjuryJan 3, 2025Break; Thermal Decomposition of Device; Detachment of Device or Device Component; Break; Thermal Decomposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE BEGINNING OF THE LASER ACTIVATION FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE BLUE-COLORED SHEATH OF THE FIBER TURNED BLACK, AND A SMALL PIECE OF THE LASER FIBER BROKE OFF AND FELL INTO THE KIDNEY. THE DOCTOR THEN REMOVED THE BROKEN PIECE AND SWITCHED TO A 200-MICRON FIBER, WHICH WAS REPORTED TO WORK WELL. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072618 ↗
• MalfunctionOct 17, 2024Smoking; Smoking

  IT WAS REPORTED THE MICRON SINGLE USE FIBER HAD A BURNING SMELL COMING FROM THE CONNECTING POINT. THE ISSUE OCCURRED DURING A THERAPEUTIC CYSTOLITHOLAPAXY PROCEDURE. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474435 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THE SINGLE USE FIBER HAD THE GLASS TIP COME OFF. THE EVENT OCCURRED DURING A BLADDER STONES REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235575 ↗
• MalfunctionAug 7, 2024Break; Break

  THE ISSUE OCCURRED DURING A DIAGNOSTIC CYSTOSCOPY PROCEDURE WITH LASER LITHO FOR BLADDER STONES. THERE WAS A DELAY OF 1 MINUTE AND THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929676 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THE LASER FIBER BROKE IN HALF. THE ISSUE OCCURRED DURING PREPARATION FOR USE BEFORE AN UNSPECIFIED PROCEDURE. 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 19679992 ↗
• MalfunctionJun 23, 2024Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing

  IT WAS REPORTED THAT 4 LASER FIBERS WORE DOWN AND ONE FIBER TIP WAS COMPLETELY MISSING DURING A THERAPEUTIC, LASER LITHOTRIPSY OF THE BLADDER STONE PROCEDURE. THE PROCEDURE WAS COMPLETED, HOWEVER MULTIPLE LASER FIBERS WERE USED. THE PROCEDURE WAS PROLONGED APPROXIMATELY 10 MINUTES DUE TO OPENING ADDITIONAL FIBERS. THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED BY APPROXIMATELY TEN MINUTES. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591811 ↗
• MalfunctionJun 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT 4 LASER FIBERS WORE DOWN AND ONE FIBER TIP WAS COMPLETELY MISSING DURING A THERAPEUTIC, LASER LITHOTRIPSY OF THE BLADDER STONE PROCEDURE. THE PROCEDURE WAS COMPLETED, HOWEVER MULTIPLE LASER FIBERS WERE USED. THE PROCEDURE WAS PROLONGED APPROXIMATELY 10 MINUTES DUE TO OPENING ADDITIONAL FIBERS. THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED BY APPROXIMATELY TEN MINUTES. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591796 ↗
• MalfunctionJun 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT 4 LASER FIBERS WORE DOWN AND ONE FIBER TIP WAS COMPLETELY MISSING DURING A THERAPEUTIC, LASER LITHOTRIPSY OF THE BLADDER STONE PROCEDURE. THE PROCEDURE WAS COMPLETED, HOWEVER MULTIPLE LASER FIBERS WERE USED. THE PROCEDURE WAS PROLONGED APPROXIMATELY 10 MINUTES DUE TO OPENING ADDITIONAL FIBERS. THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED BY APPROXIMATELY TEN MINUTES. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591794 ↗
• MalfunctionJun 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT 4 LASER FIBERS WORE DOWN AND ONE FIBER TIP WAS COMPLETELY MISSING DURING A THERAPEUTIC, LASER LITHOTRIPSY OF THE BLADDER STONE PROCEDURE. THE PROCEDURE WAS COMPLETED, HOWEVER MULTIPLE LASER FIBERS WERE USED. THE PROCEDURE WAS PROLONGED APPROXIMATELY 10 MINUTES DUE TO OPENING ADDITIONAL FIBERS. THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED BY APPROXIMATELY TEN MINUTES. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591789 ↗
• MalfunctionJun 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT 4 LASER FIBERS WORE DOWN AND ONE FIBER TIP WAS COMPLETELY MISSING DURING A THERAPEUTIC, LASER LITHOTRIPSY OF THE BLADDER STONE PROCEDURE. THE PROCEDURE WAS COMPLETED, HOWEVER MULTIPLE LASER FIBERS WERE USED. THE PROCEDURE WAS PROLONGED APPROXIMATELY 10 MINUTES DUE TO OPENING ADDITIONAL FIBERS. THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED BY APPROXIMATELY TEN MINUTES. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591786 ↗
• MalfunctionFeb 17, 2024Fire; Fire

  IT WAS REPORTED THAT THE 550 MICRON TFL SINGLE USE FIBER CAUGHT ON FIRE. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728221 ↗
• MalfunctionFeb 9, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PHYSICIAN LOST CONTROL OF THE DISTAL TIP OF THE 550 MICRON TFL SINGLE USE FIBER PRIOR TO THE START OF A PROCEDURE AND THE LASER BEAM MADE CONTACT WITH A LAB COAT OF ONE OF THE PERSONS IN THE ROOM AND BURNED IT. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679298 ↗
• MalfunctionJan 5, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE 550 MICRON TFL SINGLE USE FIBER BROKE DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450108 ↗
• MalfunctionJan 3, 2024Smoking; Smoking

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS SINGLE USE LASER FIBER WAS USED IN CONJUNCTION WITH THE OLYMPUS POWERED LASER SURGICAL INSTRUMENT WHEN THE DEVICE WOULD NOT TURN ON. THE CUSTOMER HEARD A POP AND THE DEVICE STARTED SMOKING FROM THE EXHAUST FAN AND WOULD NOT TURN ON. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6) (POWERED LASER SURGICAL INSTRUMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436746 ↗
• MalfunctionDec 1, 2023Fracture; Fracture

  THE OLYMPUS SALES REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE OF ONE SINGLE USE LASER FIBER. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A CYSTOLITHOLAPAXY PROCEDURE. AS REPORTED, WHEN THE CUSTOMER REMOVED THE LASER FIBER FROM ITS SLEEVE, THEY NOTICED THE END OF THE FIBER WAS CRACKED. THE CUSTOMER COMPLETED THE PROCEDURE USING ANOTHER OF THE SAME DEVICE FROM THE SAME LOT. AS REPORTED, THERE WAS NO DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249240 ↗
• MalfunctionOct 10, 2023Smoking; Smoking

  THE CUSTOMER REPORTED THAT THE FACILITY'S TFL-PLS POWER SUPPLY FAILED AND THEN THE UNIT BEGAN SMOKING. THE EVENT WAS FOUND DURING PREPARATION FOR USE IN AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT INCLUDES TWO (2) REPORTS . REPORT WITH PATIENT IDENTIFIER (B)(6), MODEL TFL-PLS , SERIAL NUMBER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6) TFL-FBX550S, LOT UNKNOWN. THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6), TFL-FBX550S, LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908375 ↗

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-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