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

Catalog Number 8065751613

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

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 that there was a bubble during a vitreoretinal procedure.The product was replaced and the procedure was completed without consequences to the patient.Additional information has been requested.A product sample was received at the manufacturing site and it is awaiting evaluation.

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue.The device history record shows the product was released per specifications.Only the cassette with drain bag was returned for visual and functional testing.No obvious defects were observed.Lab stock components were used to replace missing items and continue testing.A console representing the current software version was used to test the sample.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular pressure calibration successfully.No anomalies were observed during priming.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.No message code appeared on the screen.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established; the returned sample met specifications.(b)(4).

• Brand Name: CONSTELLATION 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: 5630658
• MDR Text Key: 45097772
• Report Number: 1644019-2016-00742
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 8065751613
• Device Lot Number: 1837881H
• Other Device ID Number: 380657516131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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
• Patient Outcome(s): Other