VITAL VUE
Received Dec 1, 2017 · Event occurred Nov 16, 2017
Report 7074260 · MDR key 7074260
Device
Generic name
Illuminator, Fiberoptic, Surgical Field
Manufacturer
Covidien LpModel number
8886828106Catalog number
8886828106
Lot number
161900107M
Product problems
- Device Operates Differently Than Expected
Patient
42 YR
- Erythema
- Swelling
- Erythema
- Swelling
Narrative
Description of Event or Problem
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.