N/A 9734261 (UDI 00643169510531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169510531), received between Jul 25, 2017 and Jul 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 26, 2018Terminated

   An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

   Z-0552-2019 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionJul 25, 2017Use of Device Problem; Device Operates Differently Than Expected; Use of Device Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT PRIOR TO A VISUALASE PROCEDURE, THE SURGEON MONITOR ON THE NAVIGATION SYSTEM BEGAN FLICKERING. THE SYSTEM WAS ON FOR A FEW HOURS WHEN THE ISSUE BEGAN. THE CABLE CONNECTIONS WERE CHECKED AND THE MONITOR WAS RESEATED TO THE MAIN CART CONNECTION WITH NO CHANGE. THE CASE WAS CONTINUED WITH THE FLICKERING MONITOR. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE OR IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742481 ↗