Stealthstation® S7™ 9733857RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994603685), received between Feb 10, 2021 and Nov 15, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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 16, 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.

• MalfunctionNov 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THE MONITOR CABLE HAD BEEN REPLACED AND WAS IN THE PROCESS OF BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814691 ↗
• MalfunctionApr 12, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM WOULD NOT BOOT UP AND SHOWS NO SIGNAL MESSAGE. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THE COMPUTER. THE NEXT STEP WAS TO REPLACE THE COMPUTER. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING THE SITE VISIT THE MANUFACTURER REPRESENTATIVE FOUND OUT THAT THE COMPUTER DOESN'T POWER ON DESPITE THE FACT THAT AC POWER IS COMING IN. MOST LIKELY THE POWER SUPPLY OF THE COMPUTER IS OUT OF ORDER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MANUFACTURER REPRESENTATIVE FOUND THE ISSUE WHEN THEY WERE CHECKING UP ON THE SYSTEM THE DAY BEFORE PERFORMING A PROCEDURE. TROUBLESHOOTING WAS PERFORMED AND THE SYSTEM WAS SHOWING NO SIGNAL. THE SYSTEM WAS RESTARTED TWICE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648486 ↗
• MalfunctionFeb 10, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE COMPUTER INTERMITTENTLY FREEZES AND HAS TO BE RESTARTED TO FUNCTION. THE NEXT STEP WAS TO REPLACE THE COMPUTER. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307881 ↗