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

Catalog Number 8065750541

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

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

A physician reported that there was no fluid coming out from the tubing during surgery.The product was replaced and the surgery was completed.There was no patient harm.

Manufacturer Narrative

Additional information provided in h.3, h.6 and h.10 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.It was reported by the customer that ¿no fluid came through tubing".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.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

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.One wet fluidics management system (fms) was visually inspected and functionally tested.No defects were observed.The ball in the drip chamber check valves moved freely per specification.The sample primed and tuned successfully.Vacuum, irrigation, and aspiration were tested at appropriate settings and met specifications.No message code, no fluid or air leaks were found on the cassette, and no defects were found.No occlusion was found in all manifolds.No leakage was detected on the irrigation and aspiration tubing insertion to the housing and fitting connection.The interface welding of the cover and the base were in good condition.The sample passed functionality testing.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After the investigation of this complaint, it has been determined that this sample met specifications.Therefore, no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: LAUREATE 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: 11629431
• MDR Text Key: 244382163
• Report Number: 1644019-2021-00238
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657505418
• UDI-Public: 00380657505418
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 8065750541
• Device Lot Number: 2395543H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 05/28/2021; 07/08/2021
• Supplement Dates FDA Received: 05/31/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1