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 Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
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 customer reported that the fluid air exchange would fill with gas but would not exchange during surgery.The procedure and patient harm details was not reported.
Additional Manufacturer Narrative
As a result of an internal review of the file, it was determined that the information provided for this event product would fill with gas but would not exchange does not represent a reportable device malfunction and it is not likely that a recurrence would result in serious injury.The initial report was submitted in error.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
As a result of an internal review of the file, it was determined that the information provided for this event product would fill with gas but would not exchange does not represent a reportable device malfunction and it is not likely that a recurrence would result in serious injury.The initial report was submitted in error.

• 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: 17940053
• Report Number: 1644019-2023-01437
• Device Sequence Number: 6350643
• Product Code: LRO
• UDI-Device Identifier: 00380657510146
• UDI-Public: 00380657510146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 15PKVK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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