FullFire® Select Diffusing Tip Laser Probe 20624-00 (REF FFS002-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816589020755), received between Jul 25, 2017 and Oct 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 24, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THERE WERE NO NOTICEABLE DEFECTS THERE WERE DETECTED DURING CONNECTION. HOWEVER, DURING ABLATION, THERE WAS NO HEATING AND UPON INSPECTION, THE LASER HAD AN OPENING ON THE SIDE OF THE BLACK CABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001517 ↗
• MalfunctionApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BACKGROUND: MONTERIS MEDICAL ISSUED A SAFETY NOTIFICATION TO ALL NEUROBLATE USERS ON OCTOBER 5, 2017 IN ORDER TO MITIGATE A RISK OF CERTAIN MRI SYSTEMS THAT HAVE BEEN SHOWN TO INTERACT WITH THE NEUROBLATE PROBE AND CREATE UNINTENDED HEATING AT THE PROBE TIP. AMONG OTHER INFORMATION THE SAFETY NOTIFICATION PROVIDED INSTRUCTION TO UTILIZE CERTAIN MRI SCANS THAT WERE SHOWN TO PREVENT THE OCCURRENCE OF THE MALFUNCTION. IT WAS REPORTED IN THIS CASE THAT A HEALTH CARE PROFESSIONAL (HCP) PERFORMED AN MRI SCAN THAT WAS NOT CONSISTENT WITH INFORMATION PROVIDED PREVIOUSLY IN THE FORM OF A SAFETY ADVISORY NOTICE. AS WITH ALL NEUROBLATE PROCEDURES A MONTERIS EMPLOYEE WAS IN ATTENDANCE AT THE PROCEDURE IN A SUPPORT ROLE. DURING THE NEUROBLATE PROCEDURE, THE MONTERIS EMPLOYEE NOTICED ANOMALOUS DATA IN THE PROBE THERMOCOUPLE READING AS REPORTED BY M-VISION SOFTWARE. THE MONTERIS EMPLOYEE THEN NOTICED THE INCORRECT MRI SCAN WAS BEING PERFORMED AND INSTRUCTED THE HCP TO STOP THE MRI SCAN. THE HCP THEN PROMPTLY STOPPED THE MRI SCAN. THESE EVENTS WERE REPORTED TO OCCUR OVER THE COURSE OF APPROXIMATELY 5 SECONDS. A 3D T1 MRI SCAN WAS COMPLETED WHICH SHOWED NO ABNORMALITIES, AND THE PROCEDURE PROCEEDED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7402925 ↗
• MalfunctionJul 25, 2017Unintended Magnet Quench; Device Operational Issue; Unintended Magnet Quench; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE BOLT WAS BEING PLACED WITH A STARFIX STEREOTACTIC DEVICE. PRIOR TO THE INSERTION OF THE PROBE, THE 2.2MM DILATOR WAS INSERTED. IT WAS INTENDED TO BE PASSED TO 1CM SHORT OF THE TARGET IN ORDER TO CONFIRM PLACEMENT. HOWEVER, THE SCAN SHOWED THAT THE DILATOR WAS PASSED 2.5CM DEEPER AND NEAR THE PATIENT'S OPTIC NERVE. IT WAS NOTED THAT THE PATIENT HAD NO DEFICITS UPON WAKING UP; IT SHOULD ALSO BE NOTED THAT THE TOLERANCE OF THE STARFIX-NEUROBLATE ADAPTER WAS TOO TIGHT WHICH CAUSED THE PHYSICIAN TO PUT A LOT OF FORCE ON THE DILATOR UPON INSERTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6740563 ↗