MAUDE Adverse Event Report: COOPER SURGICAL, INC. ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM; TUBE, SMOKE REMOVAL, ENDOSCOPIC

Model Number 0620-030-606

Device Problems Material Discolored (1170); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM
• Type of Device: TUBE, SMOKE REMOVAL, ENDOSCOPIC
• Manufacturer (Section D): COOPER SURGICAL, INC. ; trumbull CT 06611
• MDR Report Key: 9596243
• MDR Text Key: 175667818
• Report Number: MW5092298
• Device Sequence Number: 1
• Product Code: FCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 0620-030-606
• Device Catalogue Number: 0620-030-606
• Device Lot Number: 269501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1