SideFire® Directional Laser Probe 20368-000 (REF NBP-000-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816589020816), received between Oct 24, 2018 and Nov 7, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, UPON CHECKING THE LASER TIP PRIOR TO INSERTING THE PROBE, THE LIGHT LOOKED DIM. THE CLINICAL SPECIALIST THEN INSPECTED THE UMBILICALS AND NOTED RED LASER LIGHT WAS VISIBLY NOTICEABLE CLOSE TO THE WHITE AND YELLOW DEPTH LOCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046516 ↗
• MalfunctionOct 25, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE LASER LIGHT COULD NOT BE SEEN AT THE TIP OF THE PROBE AFTER THE FIBER WAS PLUGGED IN. IT WAS ALSO NOTED THERE WAS LASER LIGHT SEEN ALONG THE FIBER CABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005204 ↗
• MalfunctionOct 24, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE LASER FIBER OF THE PROBE BURNED ABOVE THE PORTABLE CONNECTOR MODULE (PCM) CONNECTION. UPON STARTING THE LASER ABLATION, THE HEAT WAS INCREASING AT A SLOW RATE ON THE NOISE MASK. THE USER THEN STOPPED LASING AND THE CLINICAL SPECIALIST (CS) WENT INTO THE MAGNET BAY AND IMMEDIATELY SMELLED BURNING PLASTIC. IT WAS NOTED THAT ABOVE THE LASER FIBER PLUG, THE FIBER WAS CHARRED. THE PROBE WAS THEN DISCONNECTED AND A NEW PROBE WAS INSERTED. THE USER WAS ABLE TO CONTINUE WITH THE ABLATION WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001619 ↗