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

Catalog Number 8065752201

Device Problems Device Alarm System (1012); Suction Problem (2170); Appropriate Term/Code Not Available (3191)

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

Event Date 11/25/2021

Event Type  malfunction  

Event Description

A physician reported an occlusion tone was heard which was not the usual noise with a poor aspiration when they started digging the furrows (quad) quadrant during the procedure.An error message was also displayed.The cassette was changed and the procedure was completed.There was no patient harm.

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).

Manufacturer Narrative

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.Based on our findings, no trending was identified.The sample was received; however, the sample was inadvertently misplaced.A careful and comprehensive search for the sample was completed; regrettably, the sample was not found after an exhaustive search.If a sample is found at a later date, the investigation will be reopened and the sample evaluated.The root cause of the customer's complaint could not be established as the sample was unable to be evaluated.After the investigation of this complaint, it has been determined that no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The returned sample was visually inspected and functionally tested.No defects were observed.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The sample primed and tuned with a handpiece successfully.The sample could be recognized and the service data could be retrieved from the console.Maximum vacuum was achieved during priming sequence and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the bss (balanced salt solution) bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Current tracking indicates no adverse trend for this lot for this event as the product met specifications.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13083305
• MDR Text Key: 282775648
• Report Number: 1644019-2021-00861
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: 00380657522019
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065752201
• Device Lot Number: 2482854H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; HAND PIECE; HAND PIECE