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

Catalog Number	8065751768
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 nurse reported the water leaked from the cassette before a vitrectomy procedure.The cassette was replaced with another one and the procedure was completed.This occurred twice and there was no patient involvement.
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.Two combined consumable fluidics management system (fms) cassettes paks were returned and visually inspected.Surgical residue was in the cassettes and manifolds.The barb of the light blue auxiliary port (aux) suction connector was broken in the first sample, stress marks were observed, on the broken area.The submerge leak test was performed on both cassettes and no leakage was detected.The samples were tested with the returned irrigation and aspiration (i/a) manifold from sample two using a calibrated console representing the current software version.The samples primed and tune with the ultrasonic handpiece, the 0.9mm air bypass (abs) tip, and the infusion sleeve from the lab stock.The samples passed the intra ocular pressure (iop) calibration successfully.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected.And no message code appeared on the screen.The cleaning process was able to be performed after functional testing was completed.The samples passed functionality testing.Based on the analysis of the returned sample, the customer's event is related to user handling.The barb of the light blue aux suction connector was broken in one of the samples.And stress marks were observed, on the broken area.A broken light blue connector barb can result in product leakage.Both samples were tested with the returned i/a manifold in good condition.And no leakage was detected.After an investigation of this complaint.It has been determined, that no action will be taken at this time as the root cause is related to improper usage.Quality assurance has reviewed this complaint 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).

• 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: 12566359
• Report Number: 1644019-2021-00604
• Device Sequence Number: 1205852
• Product Code: LRO
• UDI-Device Identifier: 00380657517688
• UDI-Public: 00380657517688
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 11/30/2022
• Device Catalogue Number: 8065751768
• Device Lot Number: 2444979H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 10/02/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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