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

Catalog Number	8065751014
Medical Device Problem Codes	Suction Problem (2170); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
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 aspiration failure and suction issue occurred during surgery.The surgery was completed after replacing the product with another one.The procedure type was unknown.There was no patient harm.
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.The auto gas fill (agf) pak was returned and visually inspected.The rear stop spacer was securely fastened to the rear adaptor.The silicone seal lips on the agf plunger sat evenly on the rear adaptor.The slot of the seal tabs was aligned to the rear adaptor slot.A calibrated console representing the current software version was used to test the sample.The sample was connected and properly recognized by the console; however, the sample failed in purging and a hissing sound occurred from the agf front assembly.Upon further evaluation, it was observed that solvent was not fully applied on the tubing insertion, causing an air leak and preventing the plunger from purging.The root cause is consistent with a manufacturing error where insufficient solvent was applied to the tubing insertion; thus, preventing the auto gas fill (agf) pak from purging as intended.This complaint has been reviewed and it is determined that no further actions will be pursued at this time.No adverse trends have been observed associated with the reported product and event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK, AUTO GAS FILL
• 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: 18137786
• Report Number: 1644019-2023-01617
• Device Sequence Number: 7992163
• Product Code: LRO
• UDI-Device Identifier: 00380657510146
• UDI-Public: 00380657510146
• 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
• Report Date (Section B): 02/19/2024

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: 8065751014
• Device Lot Number: 15PKVA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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
• Patient Sex: Unknown