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

Catalog Number 8065752435

Device Problem Difficult to Remove (1528)

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

Event Date 03/03/2021

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 the probe got stuck inside the trocar cannula during a procedure.The trocar cannula came out when probe pulled.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened 23 gauge trocar handle/blade assembly along with a cap.And the cannula/hub assembly in the cap within a pouch were received, for the report of the cutter got stuck in the trocar.The sample was visually inspected and was found to be conforming.The sample was then dimensionally inspected for cannula inner diameter and was found conforming.A functional fit test was not performed, due to the probe was not returned.The product was processed and released according to the product¿s acceptance criteria.The returned sample was found to be visually and dimensionally conforming.Therefore, a product fit issue as described in the complaint was not confirmed.And a root cause cannot be determined, for the complaint as described by the customer.No action was taken as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No further actions are required.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
• MDR Report Key: 11574882
• MDR Text Key: 242914167
• Report Number: 1644019-2021-00205
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524358
• UDI-Public: 380657524358
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 8065752435
• Device Lot Number: 2442340H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1