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

Catalog Number	8065750157
Medical Device Problem Codes	Suction Problem (2170); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A customer reported the vitrectomy probe was not cutting or aspirating properly during a procedure.The product was replaced with another one and the procedure was completed.There was no patient harm.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported the vitrectomy probe was not cutting properly and it was not aspirating properly during a cataract procedure.
Additional Manufacturer Narrative
One opened probe was received with no tip protector, in a tray.The returned sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all function tests.The returned sample was found to be conforming, therefore cut and aspiration failures 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 returned probe was manufactured to specifications.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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: INFINITI SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11740865
• Report Number: 1644019-2021-00290
• Device Sequence Number: 11706906
• Product Code: LRO
• UDI-Device Identifier: 00380657501571
• UDI-Public: 00380657501571
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065750157
• Device Lot Number: 2293347H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 09/02/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/18/2021; 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1