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

Catalog Number 8065751468

Device Problem Material Separation (1562)

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

Event Date 11/13/2020

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.(b)(4).

Event Description

A nurse reported that during the process of puncture, a cannula separated from the bayonet, and the cannula could not be used normally.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; however the attached customer photo confirms the reported issue of the trocar cannula separated from the bayonet.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 customer photo confirms the report of the trocar cannula and hub separated; however, since a sample was not received at the manufacturing site and how and when the trocar became separated could not be determined, a root cause for the trocar separation could not be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The returned sample #1 trocar hub was visually inspected and was found to be non-conforming, there was no trocar cannula.There was presence of adhesive inside of the hub.Samples 2 and 3 were visually inspected and were found to be conforming.Functional testing for push out test was then performed.Samples 2 and 3 were found conforming, while sample 1 could not be tested due to only the hub being returned.A photo was reviewed.The photo is of a trocar and there is separation of the hub and cannula that confirms the reported issue of the trocar became separated.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned hub sample #1 identified adhesive inside of the hub, therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.Samples #2 and #3 were visually and functionally conforming; therefore a trocar cannula separated as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.No additional action is required at this time.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: 10867501
• MDR Text Key: 218236158
• Report Number: 1644019-2020-00618
• 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,Followup
• Report Date: 06/01/2021

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: 06/30/2021
• Device Catalogue Number: 8065751468
• Device Lot Number: 2300231H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 02/09/2021; 05/27/2021
• Supplement Dates FDA Received: 02/11/2021; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1