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

Catalog Number 8065751155

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/01/2022

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 balanced salt solution (bss) bottle air supply tube of the pak was disconnected during surgery.It was reinserted and the surgery was continued.The product was replaced and the surgery was completed.There was no patient harm.

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.The returned sample was visually inspected.Visual inspection confirmed gray tube was detached from drip chamber.Insertion mark and glue-like foreign material was observed on the tube.The root cause of the customer¿s complaint is an error that occurred during the supplier¿s assembly process.Based on the condition of the open gap, it appeared the gray airline was not fully inserted into the drip chamber spike.Action will not be taken based on this occurrence.The supplier has been made aware of the issue.No adverse trends have been observed associated with the reported product and event.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 16135370
• MDR Text Key: 307075078
• Report Number: 1644019-2023-00042
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657511556
• UDI-Public: 00380657511556
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 8065751155
• Device Lot Number: 149RLH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM