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 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the lot specific to this event is not known; therefore, lot history and device history record reviews were not possible.The customer did not retain a sample for this complaint report; visual inspection or 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; however, complaints of a similar nature referencing aspiration/suction issues have been received and the most likely root cause is an error during the supplier¿s manufacturing process of the blue aspiration luer on the system manifold.It has been noticed that the blue luer on the manifold is not creating a complete seal resulting in air flow.An action has been opened to determine root cause and implement appropriate corrective actions for complaints of this nature.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 event that happened on (b)(6) 2016.

• 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: 5499952
• MDR Text Key: 40574213
• Report Number: 1644019-2016-00520
• 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: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2016

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 Catalogue Number: 8065752200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other