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

Catalog Number ASKU

Device Problem Aspiration Issue (2883)

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

Event Date 01/19/2016

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.Additional information has been requested and received.(b)(4).

Event Description

A (b)(6) reported an issue of decrease of aspiration during irrigation/aspiration (i/a).Additional information has been requested and received.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

The previously reported "date received by mfg" was incorrect.This is the correct date.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: the lot specific to this event is not known; therefore, device history record review was not possible.The customer did not retain a sample for this complaint report; therefore, visual inspection and functional testing could not be conducted.The system operator's manual provides the following in regard to loss of aspiration/suction issues: insufficient aspiration probable cause: loose blue luer fittings.Damaged o-ring (ultraflow irrigation/aspiration handpiece only).Clogged tip.Kinked or damaged tubing.Cracked blue fitting.Recommended solutions: reconnect securely.Inspect o-ring and replace, as necessary.Flush tip with sterile water or bss sterile irrigation solution.Retest.Replace tip.Retest.Check tubing and/or replace cassette.Check fitting and/or replace cassette.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 one supplier lot of the blue aspiration luer on the system manifold.It has been determined that some of the blue luers from one of the six supplier cavities (cavity 3) from one supplier lot can allow air to enter the aspiration line and reduce the ability of the sample to reach maximum vacuum.An action has been opened to determine root cause and implement appropriate corrective actions for complaints of this nature.

Event Description

Additional information was provided by the surgeon.The surgery could not be completed due to the aspiration issues during i/a phase of an intraocular lens (iol) implant.The cassette was changed and surgery could be completed.Additional information has been requested and received.

• 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: 5499953
• MDR Text Key: 40328247
• Report Number: 1644019-2016-00522
• 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,Followup,Followup,Followup
• Report Date: 06/06/2016

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: ASKU
• Device Lot Number: ASKU
• Other Device ID Number: 2.03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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