MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC

Catalog Number 8065751658

Device Problem Leak/Splash (1354)

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

Event Date 11/03/2020

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 a leakage from the trocar before surgery, the product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of trocar leakage; 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).

Manufacturer Narrative

Three opened 25 ga trocar assemblies in a smpt were received.For the report of trocar leaking.The returned samples were visually inspected.And were found to be non-conforming with damage to the septum's.Leak testing could not be performed, due to the damage of the samples.The product was processed and released according to the product¿s acceptance criteria.The exact root cause for this complaint is unknown.The damaged condition of the valves could have contributed to the reported event.How and when the valves became damaged, cannot be determined from the evaluation performed.The exact root cause for this complaint is unknown.Therefore, specific action for this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged 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: EDGEPLUS VALVED ENTRY SYSTEM
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10802714
• MDR Text Key: 216850945
• Report Number: 2028159-2020-00930
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 8065751658
• Device Lot Number: 13LFRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1