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

Catalog Number	8065751614
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported a trocar cannula leaked during a procedure.The product was replaced with another one and it leaked.However, the procedure was completed and there was no patient harm reported.Additional information received from the surgeon who indicated only one trocar leaked during the fluid air exchange phase of the procedure which obscured surgeon¿s view.This is one of two reports.
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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(6).
Event or Problem Description
Additional information received from the reporter who indicated the trocar was replaced when it was leaking profusely however, on many occasions, where the leak was a small one that quite often squirted on the biome it had to be capped with a gauze or sponge.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Three open trocar handle blade assemblies and three cannula hub assemblies, in a small parts tray (smpt) were received.However, the reported lot number was expired when the sample was received at the manufacturing site.Therefore, no product evaluation was performed due to the reported functional issue.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Samples were returned and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria.However, when the samples were received at the manufacturing site it was determined that the samples were beyond its expiry date; therefore, a root cause was unable to be determined.No specific action with regard to this complaint was taken by the manufacturing location because the complaint samples exceeded its expiration date when the samples were received at the manufacturing site.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CONSTELLATION 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: 12931561
• Report Number: 1644019-2021-00778
• Device Sequence Number: 5568659
• Product Code: LRO
• UDI-Device Identifier: 00380657516148
• UDI-Public: 00380657516148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2024

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: 01/31/2023
• Device Catalogue Number: 8065751614
• Device Lot Number: 2455145H
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 01/31/2022; 05/17/2024
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 12/27/2021; 02/22/2022; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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: CUSTOM-PAK SURGICAL PROCEDURE PACK.; CUSTOM-PAK SURGICAL PROCEDURE PACK.
• Patient Sex: Unknown