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

Catalog Number 8065751058

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

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 Description

A physician reported cassette was found to be damaged and leaking upon opening the pak before a vitrectomy surgery.The surgery was completed after the product was replaced.There was no patient contact with the device.

Manufacturer Narrative

Additional information received in 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.A customer photo was provided; the image shows the infusion chamber with a crack propagating upward.The crack appears to propagate upward from the base of the infusion chamber where it interfaces with the pinch plate.We cannot confirm leakage by the image but droplets of water are observed and the crack is likely were fluid leakage was observed.The cassette is clear and no other damage can be observed.There are no closer images or other angles provided of the crack.The second image is of the tray labeling.No physical sample was returned for root cause evaluation and therefore the condition of the cassette could not be verified.The console is designed to perform a pressure and vacuum leak test when the cassette is inserted into the console to prevent an unwarranted condition such as the one observed in the image.While the source of the complaint is related to damage on the infusion chamber, the root cause of when and where the damage occurred could not be conclusively determined.After review of this complaint, it has been determined that no further actions will be pursued at this time.Current tracking indicates no adverse trend for this lot for this event.Each final assembled cassette is leak and flow tested to mitigate recurrence, in-process controls and product acceptance criteria continue to be acceptable.Complaint 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
• Type of Device: 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: 15551160
• MDR Text Key: 305878714
• Report Number: 1644019-2022-00792
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657510580
• UDI-Public: 00380657510580
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 8065751058
• Device Lot Number: 14E5R8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1