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

Catalog Number 8065752022

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 10/01/2015

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.A product sample was received at the manufacturing site and it is awaiting evaluation.(b)(4).

Event Description

A surgeon reported that air entered the aspiration line during a vitreoretinal procedure, and caused the efficiency of the product to drop.The reporter informed that ¿the air in the aspiration line created bubbles in the drip chamber, discharged the basic salt solution in the drip chamber, and disabled the reflux¿ in the tubing.The product was replaced and the procedure was completed without consequences to the patient.Additional information has been requested.

Manufacturer Narrative

One probe was returned for evaluation.The sample was visually inspected and found to be visually nonconforming.The needle was bent at an angle of approximately ten degrees.The tubing was correctly engaged properly into the ports, with no occlusion in the lines.Actuation testing was performed and deemed conforming.Aspiration testing was performed and deemed conforming.No air was observed in the aspiration line during testing.The probe was disassembled and the components inspected.There was approximately 30 minutes of usage wear on the inner cutter when compared to the cutter wear visual standards.For this complaint file, the final customer lot was identified.The device history record review indicated the product was released according to the product¿s acceptance criteria.The complaint evaluation does not confirm poor aspiration or air entering the aspiration line during testing.The probe actuated and aspiration per specification.The root cause of the probe aspiration efficiency drop cannot be determined from this evaluation.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5185489
• MDR Text Key: 30055917
• Report Number: 1644019-2015-01187
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 8065752022
• Device Lot Number: 1702876H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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