FiberLase™ CO2 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07290109142012), received between Jan 29, 2019 and Sep 14, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Overheating of Device

  Burn mark to mouth/lip/face resulting from break in laser fiber - heating up the metal rigid bronchoscope.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50753892 ↗
• MalfunctionMay 22, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE FIBER FAILED TO EMIT ENERGY AT ALL. ANOTHER FIBER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION DETERMINED THAT THERE WAS FOUND A FIBER TIP BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257474 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT, DURING THE INITIAL ATTEMPT TO LASE, THE CO2 FIBER BROKE INSIDE THE PATIENT AIRWAY. THE GLASS TIP OF THE FIBER DETACHED AND BROKE OFF INTO THE TISSUE UPON INSERTION INTO THE PATIENT. THE GLASS FRAGMENT WAS RETRIEVED BY THE ATTENDING SURGEON VIA SUCTION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IT WAS NOTED THAT THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986574 ↗
• MalfunctionDec 2, 2025Melted; Power Problem; Melted; Power Problem

  IT WAS REPORTED THAT DURING A LARYNGOSCOPY PROCEDURE, THERE WERE TWO FIBERS USED NOT WORKING, AS THE FIBER TIP WAS MELTED. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693005 ↗
• MalfunctionNov 28, 2025Melted; Power Problem; Melted; Power Problem

  IT WAS REPORTED THAT DURING A LARYNGOSCOPY PROCEDURE, THERE WERE TWO FIBERS USED NOT WORKING, AS THE FIBER TIP WAS MELTED. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671872 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO PROCEDURE THERE WAS A LASER FIBER THAT BROKE AT THE GLASS TIP PRIOR TO USE. ANOTHER OF THE SAME FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919610 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING PREPARATION FOR A PROCEDURE, IT WAS FOUND THAT THE FIBER FAILED AND WAS NOT ABLE TO TRANSMIT ENERGY. THE FIBER WAS REPLACED, BUT THE SECOND FIBER PRESENTED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. LABORATORY ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT NO LIGHT WAS EXITING THE CONNECTOR FACE, INDICATING A CONNECTOR INTERNAL FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204709 ↗
• MalfunctionMay 29, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING PREPARATION FOR A PROCEDURE, IT WAS FOUND THAT THE FIBER FAILED AND WAS NOT ABLE TO TRANSMIT ENERGY. THE FIBER WAS REPLACED, BUT THE SECOND FIBER PRESENTED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. LABORATORY ANALYSIS OF THE RETUNED FIBER IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106477 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE WITH THIS FIBER, THE TIP FELL OFF INSIDE THE PATIENT, AND IT HAD TO BE RETRIEVED WITH A FORCEPS DURING THE PROCEDURE. ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678309 ↗
• MalfunctionOct 15, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, AFTER 761 JOULES OF USE THE VAPORIZATION DIMINISHED. A SECOND FIBER WAS THEN TRIED AND FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE SECOND FIBER WAS RETURNED FOR ANALYSIS AND IT WAS IDENTIFIED THAT THE FIBER TIP WAS BROKEN. THEREFORE, REPORTING CRITERIA IS MET BASED ON THIS AS ANALYZED FINDING. THIS REPORT IS FOR THE 2ND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458083 ↗
• MalfunctionOct 15, 2024Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT, AFTER 761 JOULES OF USE THE VAPORIZATION DIMINISHED. A SECOND FIBER WAS THEN TRIED AND FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LASER SYSTEM WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BREAK. THIS COMPLAINT REFERS TO THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455691 ↗
• MalfunctionMar 14, 2024Overheating of Device; Defective Device; Overheating of Device; Defective Device

  IT WAS REPORTED THAT DURING A CO2 ZENKERS DIVERTICULUM PROCEDURE, THE FIBER MALFUNCTIONED, AND IT WAS ALSO NOTICED THAT THERE WAS A BURNING THROUGH PROXIMAL FIBER NEAR CONNECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. UPON RETURN OF THE FIBER, PRODUCT ANALYSIS CONFIRMED A DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908989 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER FIBERS BROKE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754070 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER FIBERS BROKE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753823 ↗
• MalfunctionFeb 14, 2024Break; Gas Output Problem; Break; Gas Output Problem

  IT WAS REPORTED THAT DURING A CO2 LAPAROSCOPY TO TREAT ENDOMETRIOSIS, THE POWER OF THE FIBER WAS DIMINISHED, THE MIDDLE OF THE FIBER BURNT IN THE SURGICAL DRAPE AND A FIBER BREAKAGE WAS REPORTED. THE FIBER BREAK SEEMED TO BE PRESENT FROM THE START OF THE PROCEDURE, SINCE LOOKED LIKE THERE WAS A HOLE IN THE FIBER. THE PROCEDURE WAS COMPLETED WITH A NEW FIBER AND THERE WERE NO PATIENT COMPLICATIONS OR INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701977 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A MICROLARYNGOSCOPY - VOCAL CORDS PROCEDURE THE TIP OF THE FIBER BROKE OFF AFTER 12 MINUTES OF USE IN CW MODE WITH 5WATTS. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935555 ↗
• MalfunctionApr 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE FIBER WORKED PROPERLY FOR A COUPLE OF MINUTES BUT THEN THE FIBER OUTPUT DECREASED. THE FIBER WAS REPLACED BUT THE SAME ISSUE OCCURRED WITH THE SECOND FIBER. THE FIBER WAS REPLACED FOR THE THIRD TIME AND THE LASER BURNED THROUGH THE FIBER. THEREFORE, THE PROCEDURE HAD TO BE STOPPED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS COMPLAINT REFERS TO THE THIRD FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820482 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT AFTER THE OPERATION, A FOREIGN OBJECT THAT APPEARED TO BE A DAMAGED TIP OF THE FIBER WAS FOUND WHILE MAKING A FINAL CHECK OF THE SURGICAL FIELD, AND IT WAS LOST BEFORE IT COULD BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782102 ↗
• MalfunctionMar 15, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE FIBER DID NOT FIRE. THE FIBER WAS REPLACED, BUT THE SECOND FIBER DID NOT FIRE EITHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURE ON THE TIP OF THE FIBER. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT REFERS TO THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549789 ↗
• MalfunctionMar 15, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE LASER ACKNOWLEDGED THE FIBER WAS GOOD. WHEN THE DEVICE WENT FROM STANDBY TO READY, IT SOUNDED AS IF IT WAS FIRING BUT NO ENERGY WAS BEING EMITTED. THE CUSTOMER HAD A BACKUP OMNIGUIDE CO2 LASER IN THE ROOM, SO THE FIBER WAS REPLACED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE FIBER WAS RETURNED, AND ANALYSIS IDENTIFIED A FRACTURE IN THE FIBER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544928 ↗
• MalfunctionMar 1, 2023Melted; Defective Device; Melted; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE COATING AROUND THE FIBER BEGAN TO DISSOLVE AND THERE WAS AN UNUSUAL ODOR. THE COATED SURFACE OF THE FIBER MELTED AT THE PROXIMAL PART OF THE FIBER. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH THE SAME FIBER. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461284 ↗
• MalfunctionDec 9, 2019Material Fragmentation; Material Fragmentation

  A FOREIGN USER FACILITY REPORTED THAT AFTER COMPLETING AN ENT PROCEDURE IN WHICH TWO (2) DISPOSABLE LUMENIS FIBERLASE FIBERS WERE UTILIZED WITH A ACUPULSE DUO LASER, THE CIRCULATING NURSE NOTED THAT "THE TIP OF THE 1ST FIBER HAD BROKEN OFF TO THE OUTER PROTECTIVE PLASTIC CLADDING." THE SURGEON PERFORMED INSPECTION OF THE PATIENT'S BRONCHUS WITH A BRONCHOSCOPE AND NO TIP WAS FOUND IN THE AIRWAY, ORAL CAVITY, OR DRAPES. THE BRONCHOSCOPE PORT WHERE THE FIBER WAS INSERTED WAS FLUSHED AND NO TIP WAS FOUND. THE PATIENT WAS THEN X-RAYED WITH NO EVIDENCE OF FIBER TIP FOUND. NO REPORT OF PATIENT INJURY OR COMPLICATIONS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9435744 ↗
• InjuryJan 29, 2019Fracture; Fracture

  A USER FACILITY REPORTED THAT DURING A ROBOTIC MYOMECTOMY PROCEDURE IN WHICH A LUMENIS ULTRAPULSE DUO WAS BEING USED WITH A LUMENIS FIBERLASE FIBER AND ROBOTIC DROP-IN-GUIDE (LUMENIS DIG), THE FIBER HAD BROKEN AND BURNED THE NURSE ANESTHETIST (CRNA). A SUPERFICIAL BURN WAS OBSERVED ON THE LEFT HAND OF THE CRNA. AS THERE WERE NO ERROR CODES WITH THE LASER, AND NO MALFUNCTION OBSERVED, A SECOND FIBER WAS PREPARED TO CONTINUE THE CASE. THE CLINICAL OPERATING ROOM DIRECTOR CAME INTO THE ROOM AND ASKED THE SURGEON TO DISCONTINUE USING THE LASER, ALTHOUGH THE SURGEON WANTED TO CONTINUE THE CASE WITH THE LASER. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY OCCURRED WITH THE PATIENT, AND THE PERSON THAT WAS BURNED ALLEGEDLY DID NOT SUSTAIN A SERIOUS INJURY.

  Patient problems: Burn(s)

  MAUDE report 8285020 ↗