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

Catalog Number	8065752088
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A physician reported that abnormal noise was heard from around the drain bag joint of the pack during surgery.The surgery was successfully completed after replacing the product with another one.There was no patient harm and procedure type was unknown.
Additional 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.A used intrepid plus fluidics management system was visually inspected.The fluidics management system was functionally tested on an console.The sample failed to prime and generated a system message code.Less fluid flowed from the balanced salt solution bottle to the cassette.The sample passed priming and tuning with an ultrasonic handpiece.No message code, no fluid or air leaks, and no cracks on the luers were found.The irrigation and aspiration flow rates were within specification.Fluid flowed from the balanced salt solution bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion was found in all manifolds.The returned drip chamber was then connected back to the sample to check for priming and fluid flow.The same failure mode occurred.The detected drip chamber prevented fluid to flow to the cassette, thus the sample failed to prime.The root cause of the customer's complaint is related to the returned drip chamber which would have been caused due to an error during the suppliers manufacturing process.The supplier will be notified of this complaint and will take appropriate actions as necessary.All lots are verified that all required inspections have been performed and all acceptance criteria are met.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint via the complaint review meetings 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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19256879
• Report Number: 1644019-2024-00927
• Device Sequence Number: 17812462
• Product Code: LRO
• UDI-Device Identifier: 00380657520886
• UDI-Public: (01)00380657520886(17)241130(11)221212(10)157YFU(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 8065752088
• Device Lot Number: 157YFU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/28/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/27/2024; 10/25/2024
• Date Device Manufactured: 12/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITI VISION SYSTEM.
• Patient Sex: Unknown