NeuroBlate Optic SideFire® Laser Probe 20891-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816589020892), received between Sep 17, 2019 and Oct 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER THE LASER PROBE WAS INSERTED AND ABLATION HAD STARTED, NO HEAT WAS BEING SHOWN ON THE SOFTWARE. IT WAS THEN NOTICED THAT THERE WAS AN EVIDENT KINK ON THE LASER PROBE UMBILICALS WHERE THE LASER FIBER EXTENDS. THE LASER PROBE WAS REPLACED WITH A NEW ONE AND THE CASE RESUMED WITH NO FURTHER ISSUES REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290534 ↗
• MalfunctionOct 23, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE TESTING THE LASER OUTPUT PRIOR TO INSERTION, THE LASER LIGHT WAS VISIBLY EMITTING WITHIN THE WHITE CORD THAT LEADS TO THE LASER CONNECTOR. IT WAS NOTED IT THE DAMAGE MAY HAVE OCCURRED WHILE BEING REMOVED FROM THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226688 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PHYSICIAN NOTICED THE TIP OF THE PROBE WAS NOT SEEN UPON REMOVAL FROM THE BOLT. SCANS WERE TAKEN TO TRY TO IDENTIFY THE SAPPHIRE TIP BUT IT WAS LATER FOUND ON THE FLOOR IN THE OPERATING ROOM. THE PHYSICIAN REPORTED THAT THE ABLATION ZONES LOOKED "GOOD" IN THE SOFTWARE BUT THAT AFTER THE CASE, POST-OPERATIVE SCANS WERE TAKEN AND THE ABLATION ZONE LOOKED MINIMAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9106385 ↗
• MalfunctionSep 18, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE LASER LIGHT WAS SHINING IN THE UMBILICALS AFTER HOOKING IT UP TO TEST THE LIGHT. THE USER REPLACED THE PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083188 ↗
• MalfunctionSep 17, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, IT WAS NOTICED THAT THE FIBER WAS BROKEN. THIS WAS DISCOVERED UPON CONNECTING LASER; THE PROBE WAS NEVER INSERTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9078968 ↗