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

Catalog Number 8065830047

Device Problems Display or Visual Feedback Problem (1184); No Flow (2991)

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

Event Date 10/05/2020

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 that solution did not come out during surgery.An alarm "replace a bottle because it is empty" was displayed on the console even though the balanced salt solution (bss) bottle had enough solution in it.The cassette was replaced and the procedure 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 customer reported that priming test was passed but solution did not come out during surgery.The returned sample was visually inspected.A short shot was observed on the barb of the gray connector on the administration manifold.The sample was tested with the defected gray connector on the administration line.The sample failed to prime and generated the system message codes 3440.The defected gray connector caused air leak during pressurizing, and restricted fluid to travel from the balanced salt solution bottle to the cassette.The root cause of the customer¿s complaint is believed to be an error that occurred during the supplier¿s manufacturing process.The supplier will be made aware of the issue; however, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action will been requested at this time.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.Consumables manufacturing has also been made aware of the issue through the monthly complaint review meeting.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
• MDR Report Key: 10741708
• MDR Text Key: 214740086
• Report Number: 1644019-2020-00571
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 8065830047
• Device Lot Number: 2268499H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM