NeuroBlate® Robotic Probe Driver 20772Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589020373), received between Jul 7, 2017 and Jul 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2017Crack; Device Operational Issue; Crack; Device Operational Issue

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS BROUGHT IN THE INTRAOPERATIVE MRI, AT THE BEGINNING OF THE CASE, AND THE PROBE DRIVE ASSEMBLY AND PROBE WERE INSERTED. AN INTRAOPERATIVE MRI DEMONSTRATED ADEQUATE PLACEMENT OF THE PROBE. INITIAL LASER ABLATION WAS THEN PERFORMED. APPROXIMATELY 50-60% OF THE TUMOR WAS ABLATED, HOWEVER, WHEN ATTEMPTING TO ROTATE THE PROBE DRIVER ASSEMBLY WAS FRACTURED. IT WAS ALSO NOTED THAT THE LENS WAS FOUND JUST BELOW THE LEVEL OF THE DURA IN THE SURFACE OF THE BRAIN. IT WAS REPORTED THAT THERE WAS EXPECTED LASER ABLATION SEEN AROUND THE PROBE BUT NO ADDITIONAL UNEXPECTED DAMAGE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6692776 ↗