MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752200

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported bubbles coming from the irrigation line and obstructing the view during the procedures.The procedures were completed with no patient harm reported.A product sample was received at the manufacturing site and it is awaiting evaluation.

Manufacturer Narrative

This is one of two complaints for the finish goods lot for this issue.The device history review shows the order was built and released per specification.The wet and used cassette was visually inspected.The drain bag was intact.The drain bag tape was aligned properly on the cassette cover.The drain bag ports were aligned properly on the cassette exit ports.No air pocket was observed between the cassette cover and the drain bag tape.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The sample was tested and could be recognized and the service data could be retrieved from the console.The sample primed and tuned successfully.No leakage occurred between the aspiration luer and the handpiece during tuning process.The irrigation and aspiration flow rates were within specification.No drop presented from the irrigation luer after the irrigation off five seconds.Neither leakage, nor occlusion was detected from the tubing insertion to the fittings and the four aspiration ports on the pump region of the cassette base.The root cause of the customer's complaint could not be established; the returned sample met specifications.(b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5669628
• MDR Text Key: 46013417
• Report Number: 1644019-2016-00810
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 8065752200
• Device Lot Number: 1857533H
• Other Device ID Number: 380657522002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other