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

Catalog Number 8065751908

Device Problem Break (1069)

Patient Problem Vitreous Loss (2142)

Event Date 01/15/2019

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 the manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported the trocars were damaged and liquid began to flow out of the eye during a vitrectomy procedure.The procedure was completed with a delay and annoyance to the patient.No known patient harm.No additional information is expected.

Manufacturer Narrative

No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are three additional complaints associated with the lot for the reported issue.The video attached to the parent complaint was reviewed by the manufacturing site.The video does confirm the a leaking trocar.No sample was returned; however the returned customer video confirmed the trocar leaked.The exact root cause for this complaint is unknown, how and when the trocar began leaking could not be determined.The exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process controls have been implemented to improve the performance of the valves.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8310637
• MDR Text Key: 135177330
• Report Number: 1644019-2019-00015
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 8065751908
• Device Lot Number: 2177659H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1