MalfunctionFCZ
ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM
Received Jan 15, 2020 · Event occurred Jan 10, 2020
Report MW5092298 · MDR key 9596243
Device
Generic name
Tube, Smoke Removal, Endoscopic
Manufacturer
Cooper Surgical, Inc.Model number
0620-030-606Catalog number
0620-030-606
Lot number
269501
Product problems
- Material Discolored
- Device Markings/Labelling Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PRODUCT LABELING ON THE COOPER SURGICAL, ULTRA PLUME-AWAY 6.0, SMOKE EVACUATION SYSTEM HAD BEEN NOTED TO BE DISCOLORED (YELLOWISH COLOR TO PORTION OF LABEL) UPON ITS ARRIVAL. FDA SAFETY REPORT ID# (B)(4).