FiberLase™ ENDURE CO2 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109142081), received between Apr 21, 2023 and Dec 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Melted; Nonstandard Device; Melted; Nonstandard Device

  IT WAS REPORTED THAT AT THE END OF A PROCEDURE, THE INSULATION FIBER PART, APPROXIMATELY 30CM FROM THE PROXIMAL PART OF THE FIBER, HAD MELTED. THE PROCEDURE WAS COMPLETED WITH ORIGINAL FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802436 ↗
• MalfunctionApr 21, 2023Use of Device Problem; Component Missing; Defective Device; Firing Problem; Use of Device Problem; Component Missing; Defective Device; Firing Problem

  IT WAS REPORTED THAT AFTER THE FIRST USE OF THE FIBER, SOMETHING AFFECTED THE DEVICE DURING THE CLEANING AND STERILIZATION PROCESS WITHIN THE FACILITY. IT WAS NOTED THAT THE DEVICE HAD BEEN LEFT IN THE DRYER ALL NIGHT AT AROUND 50 C OF CONTINUOUSLY APPLIED HEAT, ALTHOUGH THE RECOMMENDED DRYING TIME ON MANUAL IS 20 MINUTES. AN ON-SITE CHECK WAS PERFORMED AND IDENTIFIED CORRUGATED MARKS THAT APPEARED TO BE SCRATCHES ON THE FIBER SURFACE. IT WAS NOTED THAT THE MANUAL FOR THE DEVICES WAS NOT RECEIVED. ADDITIONALLY, IT WAS INDICATED THAT THE AIMING BEAM REACHED THE TIP, BUT THE LASER WOULD NOT FIRE. THE EVENT OCCURRED BEFORE THE PROCEDURE; HOWEVER, THE ANESTHESIA HAD ALREADY BEEN ADMINISTERED. THE PROCEDURE WAS NOT COMPLETED DUE TO THE SAME DEVICE BEING UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED DUE TO PROCEDURE ABORTED AFTER SEDATION WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788323 ↗
• MalfunctionApr 21, 2023Use of Device Problem; Component Missing; Defective Device; Firing Problem; Use of Device Problem; Component Missing; Defective Device; Firing Problem

  IT WAS REPORTED THAT AFTER THE FIRST USE OF THE FIBER, SOMETHING AFFECTED THE DEVICE DURING THE CLEANING AND STERILIZATION PROCESS WITHIN THE FACILITY. IT WAS NOTED THAT THE DEVICE HAD BEEN LEFT IN THE DRYER ALL NIGHT AT AROUND 50 C OF CONTINUOUSLY APPLIED HEAT, ALTHOUGH THE RECOMMENDED DRYING TIME ON MANUAL IS 20 MINUTES. AN ON-SITE CHECK WAS PERFORMED AND IDENTIFIED CORRUGATED MARKS THAT APPEARED TO BE SCRATCHES ON THE FIBER SURFACE. IT WAS NOTED THAT THE MANUAL FOR THE DEVICES WAS NOT RECEIVED. ADDITIONALLY, IT WAS INDICATED THAT THE AIMING BEAM REACHED THE TIP, BUT THE LASER WOULD NOT FIRE. THE EVENT OCCURRED BEFORE THE PROCEDURE; HOWEVER, THE ANESTHESIA HAD ALREADY BEEN ADMINISTERED. THE PROCEDURE WAS NOT COMPLETED DUE TO THE SAME DEVICE BEING UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED DUE TO PROCEDURE ABORTED AFTER SEDATION WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788317 ↗