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

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 but not received to date.(b)(4).

Event Description

A chief nurse reported that the aspiration/vacuum did not work during irrigation/aspiration step during a cataract surgery with intraocular lens implant.Another test was performed but vacuum did not work.A new cassette was used to complete the surgery.Additional information has been requested but not received to date.

Manufacturer Narrative

Evaluation summary: review of the device history record indicated that the order was built to specification.The returned sample was visually inspected and it was noted that the drain bag was detached from the cassette cover due to saturation.The sample could be recognized and the service data could be retrieved from the console.The sample primed and tuned successfully.No leakage was observed during testing.The returned sample was visually and functionally tested and passed testing.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; the returned sample met specifications.

• 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: 5453762
• MDR Text Key: 39211783
• Report Number: 1644019-2016-00404
• 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: foreign,health professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 8065752200
• Device Lot Number: 1780201H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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