NeuroBlate Optic FullFire® Laser Probe 20895-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589021035), received between Dec 27, 2018 and Aug 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2020Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, IN THE FIRST ABLATION SEQUENCE, INITIAL PROBE MOVEMENT TO THE TARGET LINEAR POSITION TIMED OUT, BUT EVENTUALLY THE PROBE REACHED THE TARGET LINEAR POSITION. INITIAL TWO LASER ABLATION SEQUENCES WERE COMPLETED. ON THE THIRD ABLATION SEQUENCE, THE PROBE WAS COMMANDED TO MOVE BUT DID NOT REACH ITS LINEAR TARGET. MANUAL ROTATION OF THE ROBOTIC PROBE DRIVER (RPD) WAS PERFORMED TO RETRACT THE PROBE TO THE TARGET POSITION, CULMINATING IN A PURELY MANUAL RPD MOVE WITH AN UNEXPECTED RAPID POSITION CHANGE. ABLATION COULD NOT BE CONTINUED AS THE IMAGE WAS NOISY, CAUSING IDL ERRORS AND PUTTING THE SYSTEM INTO SAFE MODE. DURING PROBE REMOVAL, THE OUTER SHAFT AND LENS SEPARATED FROM THE REST OF THE PROBE AND REMAINED IN THE PATIENT. NO PROBE RESISTANCE WAS NOTED WHEN THE PROBE WAS REMOVED FROM THE PATIENT. THE MINI-BOLT WAS NOTICEABLY LOOSE ON THE SKULL. CT SCANS OF THE PATIENT TAKEN POST-OP SHOWS ARTIFACTS WHICH APPEAR TO BE THE REMAINING OUTER SHAFT SEGMENT WITH THE LENS ATTACHED. THE NEXT DAY, PROBE WAS REMOVED WITHOUT REPORTED INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10408009 ↗
• MalfunctionDec 27, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THAT WHEN THE CLINICAL SPECIALIST (CS) CHECKED THE LASER OUTPUT OF THE PROBE, THERE WAS NO RED LIGHT OUTPUT. PHYSICIAN CHECKED IT BEFORE INSERTING IT SO NO PATIENT INTERFERENCE AND THEN HAD A BACK UP ONE, SO NO TIME WAS ADDED TO THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199656 ↗