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

Catalog Number 8065752201

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

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 customer reported that the infusion sleeve folded up on itself resulting in obstruction during a procedure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

There were two fluid management system finished good lots associated with the custom pak.It was not known which lot was used for this event.A review of the device history record traceable to the reported lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria for both lots.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information indicates that the surgery was performed on left eye.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information indicates that the surgery was performed on left eye.

Manufacturer Narrative

Correction provided in d.4.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 10285804
• MDR Text Key: 199873514
• Report Number: 1644019-2020-00374
• 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,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752201
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/27/2020; 07/27/2020; 08/21/2020
• Supplement Dates FDA Received: 08/10/2020; 08/20/2020; 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CUSTOM PAK; OZIL HANDPIECE