Vital Vue 8886828106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521176096), received between Dec 1, 2017 and Dec 1, 2017 — classified as 1 malfunction.

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

• MalfunctionDec 1, 2017Device Operates Differently Than Expected

  DURING THE CASE THE VITAL VUE SUCTION WAS GIVEN TO THE STERILE FIELD. A ONE LITER BAG OF SALINE WAS SPIKED AND THE TUBING WAS ATTACHED TO THE SUCTION MACHINE. THE SURGEON DRAPED THE SUCTION OVER THE PATIENTS RIGHT THIGH AS IT WAS USED INTERMITTENTLY THROUGHOUT THE CASE. WHEN HOOKING UP THE LIGHT SOURCE FOR THE CYSTOSCOPY THE NURSE NOTED THE VITAL VUE WAS DRAPED OVER THE PATIENTS LEG AND ASKED THE SURGEON IF THE VITAL VUE WAS ON. THE RESIDENT RESPONDED NO, BUT DID NOT MOVE OR CHECK IF THE LIGHT WAS ON. THE NURSE UNPLUGGED THE TUBING FROM THE VITAL VUE AT THAT TIME AND THE CASE PROCEEDED. AT THE END OF THE CASE THE DRAPES WERE REMOVED FROM THE PATIENT AND THE NURSE NOTED A RAISED REDDENED AREA WITH BLISTERS ON THE PATIENTS RIGHT INNER THIGH NEAR THE BOVIE PAD SITE. THE BOVIE PAD WAS REMOVED. THE SITE WAS UNCHANGED; NO REDNESS, SWELLING, OR SKIN CHANGES.

  Patient problems: Erythema; Swelling

  MAUDE report 7074260 ↗