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

Catalog Number 8065752436

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

A nurse reported that the tubing was detached during vitrectomy surgery and attempted to re-attach the tubing but was unsuccessful.The surgery was completed after replacing the product with new one.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.Upon visual inspection of the returned probe, both pneumatic drivelines were detached from the probe.Under magnification we confirmed the presence of adhesive residue around the tubing and a residue line on the tubing indicate both drivelines were fully inserted into the probe ports at one time.With the amount of residue remaining on the tubing for both lines, we could not conclude if this issue was the result of a adhesive application issue.The signs observed on the distal end of each tubing indicate the presence of adhesive.In order to mitigate the occurrence of this type of event, during the manufacturing process, in-process checks during assembly and after final assembly are utilized to help screen out this type of defect from occurring.The root cause of the customer's complaint could not be conclusively determined based on the result of the investigation.A potential root cause could be related to the bonding process, however, this cannot be confirmed with the available information.No root cause could be conclusively determined, therefore no corrective action is required at this time.Based on our current tracking, there are no adverse trends for this reported complaint and lot.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: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 17077788
• MDR Text Key: 316877154
• Report Number: 1644019-2023-00674
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524365
• UDI-Public: 00380657524365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065752436
• Device Lot Number: 158NYT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1