MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS TROCAR/CANNULA SET; CANNULA, TROCAR, OPHTHALMIC

Catalog Number	8065751448
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during retinal detachment/vitrectomy procedure the trocar did not have a metal sleeve.The metal sleeve was retained in the eye and in sterile field.There was no harm to the patient and the procedure was completed.There was an extended or time due to searching for the metal sleeve.
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
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened trocar assembly, in a pouch was received for the report of no metal sleeve included on the shaft.Sample was visually inspected and found to be nonconforming, hub was observed to be separated from cannula, hub was not seated right against top of cannula.Adhesive was presence on the outside of the cannula and on the inner diameter of the hub.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 photos provided by the customer were reviewed by the manufacturing site.Photos show a trocar blade/handle assembly with a trocar cannula on it and a trocar hub separated from the cannula.Reported issue confirmed from photo.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned sample 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.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.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: EDGEPLUS TROCAR/CANNULA SET
• 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: 17894215
• Report Number: 2028159-2023-01367
• Device Sequence Number: 11630600
• Product Code: NGY
• UDI-Device Identifier: 00380657514489
• UDI-Public: 00380657514489
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2024

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: 12/31/2025
• Device Catalogue Number: 8065751448
• Device Lot Number: 158XMH
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 01/11/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/14/2023; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown