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

Catalog Number	8065751657
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during surgery surgeon noted that water was leaking from the trocar.The surgery was completed with new trocar.There was no harm to patient.
Additional 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).
Additional Manufacturer Narrative
Additional information is provided in sections d.4, h.4, e.1, d.9,h.3,h,6 and h.10.Three opened trocar assemblies 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.Sample 3 also had a hole a in the septum.Leak testing could not be performed due to the damage of the samples.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Photo given by the customer was reviewed by the manufacturing site.Photo shows a pouch label, confirming the reported product and lot information.The exact root cause for this complaint is unknown; the damaged condition of the valve could have contributed to the reported event; how and when the valve became damaged cannot be determined from the evaluation performed.A possible contributing factor for the hole seen on sample 3 is that the probe was actuated during removal/insertion of the probe through the trocar valve and the probe cut the trocar septum.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS VALVED ENTRY SYSTEM
• Common Device Name: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16940745
• Report Number: 2028159-2023-00694
• Device Sequence Number: 6170906
• Product Code: NGY
• UDI-Device Identifier: 00380657516575
• UDI-Public: 00380657516575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 8065751657
• Device Lot Number: 14XJ4T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown