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

Catalog Number 8065752200

Device Problem Aspiration Issue (2883)

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

A sample has been received and in-house evaluation is in progress.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.No further information is expected.(b)(4).

Event Description

A materiovigilance referent reported decrease in aspiration during irrigation/aspiration (i/a) phase.The issue was resolved by replacing the cassette.The issue occurred in the middle of the surgery and increased the time of surgery.No further information is expected.This is one of five reports being filed for this facility.This report refers to the issue that happened on (b)(6) 2016.

Manufacturer Narrative

For the first product lot associated with this report: a device history review of the reported lot showed that the product was built to specifications.The returned was visually inspected and it was found that the drain bag was intact and properly aligned on the cassette cover.The sample could be recognized and the service data could be retrieved from the console.The sample successfully passed priming and tuning.No leakage occurred between the aspiration luer and the handpiece during the tuning process.The cavity of the aspiration fitting was cavity 1.A maximum vacuum within specification was reached during testing.The irrigation and aspiration flow rates were within specification.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 sample passed both visual and functional testing.The root cause of the customer's complaint could not be established as the returned sample met specifications.For the second product lot associated with this report; a device history review of the reported lot showed that the product was built to specifications.The customer did not retain a sample for this complaint report; therefore, visual inspection and functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.An internal investigation has been opened to address reports of a similar nature.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

For the first product lot associated with this report: a device history review of the reported lot showed that the product was built to specifications.The returned was visually inspected and it was found that the drain bag was intact and properly aligned on the cassette cover.The sample could be recognized and the service data could be retrieved from the console.The sample successfully passed priming and tuning.No leakage occurred between the aspiration luer and the handpiece during the tuning process.The cavity of the aspiration fitting was cavity 1.A maximum vacuum within specification was reached during testing.The irrigation and aspiration flow rates were within specification.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 sample passed both visual and functional testing.The root cause of the customer's complaint could not be established as the returned sample met specifications.For the second product lot associated with this report; a device history review of the reported lot showed that the product was built to specifications.The customer did not retain a sample for this complaint report; therefore, visual inspection and functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.An internal investigation has been opened to address reports of a similar nature.The manufacturer internal reference number is: (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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5499951
• MDR Text Key: 40327277
• Report Number: 1644019-2016-00521
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 8065752200
• Device Lot Number: 1810839H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CASSETTE.; CASSETTE
• Patient Outcome(s): Other