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

Catalog Number 8065752180

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.(b)(4).

Event Description

A nurse reported that the product clogged during a procedure.The product was changed and the procedure was completed.Patient impact is unknown.

Manufacturer Narrative

The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.Eight used fluidics management systems were returned for evaluation.They were visually inspected and no obvious defects were observed that would have caused or contributed to the reported event.The samples were tested using a calibrated console.The cassette was recognized properly by the console when inserted and connected.The samples primed and tuned successfully and could achieve maximum vacuum.No leakage was observed from the tubing insertions to the handpiece during tuning.The irrigation and aspiration flow rates were measured and were conforming to specifications.No damage was found on the fittings.Neither leakage, nor occlusion was detected from the tubing insertion to the fittings and the four aspiration ports on the pump region of the cassette bases during performance testing.No clogging was experienced during laboratory testing of the device.The sample functioned within specifications.The root cause of the customer's complaint could not be established as the returned samples were evaluated and met specifications.After investigation of this complaint, it has been determined that these samples functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

This is the second complaint reported for this finished goods lot and the first reported for this issue.Review of the device history report indicates the order was built to specification.A sample was not received to date for this complaint report; therefore, visual inspection or functional testing could not be conducted.Without a sample it cannot be determined if there were any physical anomalies that led to the customer's experience.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.No action will be taken for this occurrence, as the root cause is unknown and a sample was not returned.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.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.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, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8034161
• MDR Text Key: 126166406
• Report Number: 1644019-2018-00259
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 8065752180
• Device Lot Number: 2123681H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 03/28/2019
• Supplement Dates FDA Received: 01/04/2019; 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK