N/A 9733157Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994231413), received between Aug 21, 2020 and Jan 8, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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.

• MalfunctionJan 8, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING STERILIZATION, THE BALL HOUSINGS CAME OFF. THE INSTRUMENT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003108 ↗
• MalfunctionNov 22, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE PROBE WOULD NOT TRACK WHEN IN THE CAMERA'S FIELD OF VIEW. IF COVERING ONE SPHERE, THE PROBE WOULD SHOW AS "YELLOW" IN THE TRACKING VIEW. WITH ALL FOUR SPHERES SHOWING, THE INSTRUMENT WOULD DISAPPEAR FROM TRACKING. THE ACCOUNT HAD ANOTHER PROBE THAT WORKED WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE SAID THERE VERY WELL COULD BE PHYSICAL DAMAGE TO THE INSTRUMENT. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE MOST LIKELY / SUSPECTED CAUSE OF THE EVENT WAS THE PROBE WAS MISHANDLED AT THE FACILITY AND THE PROBE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758120 ↗
• MalfunctionAug 21, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY. IT WAS REPORTED THAT A PROBE WOULD NOT TRACK. THE INSTRUMENT WAS ADDED TO THE PROCEDURE, AND WOULD FLICKER ON THE SCREEN, AND THEN IMMEDIATELY STOPPED TRACKING. THE PROCEDURE CONTINUED WITH NAVIGATION, BUT WITHOUT THE BIOPSY SYSTEM. AFTER THE CASE, THE MANUFACTURER REPRESENTATIVE BROUGHT THE INSTRUMENT INTO THE TRACKING VOLUME AND THE PROBE WORKED WHEN ONE OF THE TOP SPHERES WERE REMOVED/COVERED. SHE COVERED THE TOP RIGHT SPHERE, AND THE PROBE WAS ABLE TO BE TRACKED. THE SAME WAS DONE WITH THE TOP LEFT SPHERE, AND THE PROBE WAS STILL ABLE TO BE TRACKED. WHEN BOTH SPHERES WERE UNCOVERED, THE PROBE WAS NOT ABLE TO BE TRACKED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10438552 ↗