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

Catalog Number 8065751462

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

A physician reported that cassette occurred leakage before the vitrectomy surgery.The surgery was completed after replacing the product.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.The returned sample was visually inspected, and pump elastomer was slightly lifted.A pressure leak test was then conducted on the cassette utilizing an external pressure source and fluid leakage was observed between the infusion chamber and pinch plate of the cassette.The source of the customer's complaint is due to a leak between the infusion chamber and pinch plate.This issue is consistent with an inadequate weld between the two components which will cause the cassette to fail during console setup and result in the customer's experience.The root cause of the leak is related to a weld error between the infusion chamber and cassette pinch plate.While the elastomer was lifted in returned condition, manufacturing 100% leak and flows each cassette after assembly and this issue would have been detected and rejected.It's possible the elastomer was lifted post-receipt of the sample.No action will be taken for this occurrence.Based on our current tracking, there are no adverse trends for this reported complaint and lot.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met to mitigate reoccurrence of this complaint issue.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: 16834318
• MDR Text Key: 314230042
• Report Number: 1644019-2023-00497
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657514625
• UDI-Public: 00380657514625
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751462
• Device Lot Number: 14WPRX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1