MAUDE Adverse Event Report: COOPER SURGICAL, INC. ULTRA PLUME AWAY 6.0; LAPAROSCOPIC SMOKE EVACUATOR

Model Number 0620-030-606

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Cooper surgical inc., ultra plume away 6.0 was received in the sterile packaging with the suction tubing bent over the tubing connector to the point where the memory of the tubing could not be corrected, and the device could not be utilized.

• Brand Name: ULTRA PLUME AWAY 6.0
• Type of Device: LAPAROSCOPIC SMOKE EVACUATOR
• Manufacturer (Section D): COOPER SURGICAL, INC. ; trumbull CT 06611
• MDR Report Key: 8180620
• MDR Text Key: 131168585
• Report Number: MW5082278
• 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: 12/17/2018

1 Device was Involved in the Event

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: 10/05/2021
• Device Model Number: 0620-030-606
• Device Catalogue Number: 0620-030-606
• Device Lot Number: 256710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• 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
• Patient Age: 37 YR