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

Catalog Number 8065830030

Device Problem Leak/Splash (1354)

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

Event Date 01/20/2021

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 customer reported that leakage occurred from a valved trocar during surgery.The surgery was completed after replacing the product with another one.The procedure type is unknown.The sample is not available because it was used on a patient with an infection and discarded.There's no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of there was leakage from the valved trocar therefore, the condition of the product could not be verified.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.Because a sample was not received at the manufacturing site and the device history record review indicated that the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.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: 11293128
• MDR Text Key: 231983189
• Report Number: 1644019-2021-00077
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065830030
• Device Lot Number: 2290897H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION LXT JAPAN, (B)(4),