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 Visual Impairment (2138)

Event Date 10/20/2016

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.(b)(4).

Event Description

A customer reported "a lot bubbles" during surgery, which "hindered the surgeon's vision.".The procedure was completed with the same product.There was no patient harm.A product sample has been requested for evaluation.

Manufacturer Narrative

A device history record review for the reported lot shows that the order was built to specification.One wet, used fluidics management system was returned for this complaint.The sample was visually inspected and surgical debris and viscoelastic substance was found in the aspiration line.It was also noted that the drain bag was detached from the cassette cover due to saturation.The surgical debris was attempted to be purged from the aspiration line; however, the substance was too solid to purge.The aspiration tubing was cut one inch from the cassette insertion and the aspiration line was replaced with one from the lab stock.The sample was functionally tested with the lab stock aspiration line and passed testing.The root cause of the occluded surgical debris and viscoelastic in the aspiration line is unknown.One potential root cause is excessive use as the sample was returned used.When the occluded aspiration line was replaced with one from the lab stock, the sample met specifications.In future testing, even if the tubing is occluded with surgical debris, the sample will be functionally tested to attempt to replicate the customer's complaint on the console.(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: 6099211
• MDR Text Key: 60298109
• Report Number: 1644019-2016-01429
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 8065752200
• Device Lot Number: 1902187H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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
• Treatment: CENTURION VISION SYSTEM
• Patient Outcome(s): Other