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

Catalog Number	8065751618
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
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 nurse reported that no air flow in fluid and air exchange mode during vitrectomy surgery.The surgery was completed by replacing with another one.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9., 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.Upon visual inspection of the returned cassette an identification (id) tab on the pinch plate was broken off.When the cassette was inserted onto a calibrated console the cassette was recognized as a posterior cassette with manual stopcock(incorrect) and passed priming and intraocular pressure (iop) calibration successfully.The ¿manual stopcock¿ output displayed by the console for the posterior cassette is incorrect for the cassette type and will result in fluid/air exchange (fax) detection issues the customer experienced.During fax mode, there was no exchange from liquid to air, liquid continued to flow to the infusion cannula.The customer's experience was replicated during laboratory testing.The investigation identified several potential factors that caused or contributed to this reported event.These include procedural gaps regarding post-inspection instructions, physical impact during storage and material movement of the pinch plate and/or cassette, and stress points due to limited surface area on the identification (id) tab.Action was taken to determine root cause and implement appropriate corrective action.To address root cause procedural enhancements were added to the visual inspection instructions for more control of non-conforming product and finite stress analysis will be performed that will aim on reducing the potential stress points on the id tabs.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).
Additional Manufacturer Narrative
As per further review of the file, evaluation code was changed from d1101 to d03 the manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 18461806
• Report Number: 1644019-2024-00036
• Device Sequence Number: 12532422
• Product Code: LRO
• UDI-Device Identifier: 00380657516186
• UDI-Public: 00380657516186
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 07/22/2024

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: 12/31/2024
• Device Catalogue Number: 8065751618
• Device Lot Number: 159CWJ
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 03/14/2024; 07/11/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 04/11/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Sex: Unknown