MAUDE Adverse Event Report: LEXION MEDICAL LLC PNEUVIEW XE LAPAROSCOPIC SMOKE ELIMINATION; TUBE, SMOKE REMOVAL, ENDOSCOPIC

Model Number 9660-XE

Device Problem Material Separation (1562)

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

Event Date 04/14/2020

Event Type  malfunction  

Event Description

Tubing from lexion medical pneuview xe became separated at the molded, white coupler during the case.Fda safety report id#: (b)(4).

• Brand Name: PNEUVIEW XE LAPAROSCOPIC SMOKE ELIMINATION
• Type of Device: TUBE, SMOKE REMOVAL, ENDOSCOPIC
• Manufacturer (Section D): LEXION MEDICAL LLC; st. paul MN 55103
• MDR Report Key: 9972000
• MDR Text Key: 188408954
• Report Number: MW5094181
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: 9660-XE
• Device Catalogue Number: 9660-XE
• Device Lot Number: 082080001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 26 YR