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

Catalog Number 8065752437

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2020

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 air entered from the 3-way stopcock during surgery.The surgery was completed after replacing the product with another one.There's no patient harm.

Manufacturer Narrative

Additional information provided in d.10, h.3, 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 only the unused yellow stopcock in the tray was visually inspected and no obvious defects were found.A calibrated console representing the current software version was used to test the sample.No leakage was found from the sample.The yellow stopcock is an accessary medical device that does not generate air function.Without returning the entire pack, the customer report could not be confirmed.Unknown.As the customer did not return all components associated with this complaint sample, a full evaluation could not be performed.As described, it is important to remind the customer to return all products associated with the event for a full evaluation.No action will be taken for this occurrence, as the root cause is unknown.No obvious defects were found on the returned stopcock.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.Consumables manufacturing has been made aware of this complaint (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
• MDR Report Key: 10606135
• MDR Text Key: 209421758
• Report Number: 1644019-2020-00526
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 8065752437
• Device Lot Number: 2337015H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM