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

Catalog Number 8065752081

Device Problems Collapse (1099); Disconnection (1171); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

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

The irrigation line disconnected from hand-piece during a procedure.The anterior chamber could not be maintained and collapsed.The shape tubing luer is bent.The product was replaced and procedure completed.

Manufacturer Narrative

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.The two wet fluidic management system's (fms¿s) were visually inspected.The first sample had no obvious defects.For the second sample, the white male fitting was bent without any stress mark.The samples were tested using the infiniti console.The samples primed and tuned with the ultrasonic handpiece and a lab stock tip and infusion sleeve successfully.The bend on the male fitting started at the entrance of the handpiece and did not affect the connection of the fitting to the handpiece.No leakage occurred during priming sequence.Vacuum, aspiration, and irrigation functionalities were tested at appropriate settings and passed all tests.While the customer¿s complaint was confirmed, testing of the sample showed that the bend was cosmetic and did not affect the performance of the product.As there are no stress marks, the root cause is related to the supplier's manufacturing process.After the investigation of this complaint, it has been determined that no action will be taken at this time.The supplier has been made aware of the issue and quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.Consumables manufacturing has also been made aware of the issue through the monthly complaint review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI 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: 11229684
• MDR Text Key: 229812923
• Report Number: 1644019-2021-00058
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 8065752081
• Device Lot Number: 2386796H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1