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

Catalog Number 8065751014

Device Problems Disconnection (1171); Fitting Problem (2183)

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

Event Date 01/30/2024

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that the tube was found disconnected, auto gas fill syringe part was touching a stopper from the beginning, however the syringe was fixed during vitrectomy surgery.The surgery was completed after replacing the product with another product.There was no patient harm.

Manufacturer Narrative

Based on the information received following submission of the initial report, this event ¿tube found disconnected, syringe part was touching a stopper¿ during surgery does not meet criteria for reporting as a reportable malfunction since it was only issue with auto gas filling not with the cassette.The manufacturer internal reference number is: (b)(4).

Event Description

Based on the information received following submission of the initial report, this event ¿tube found disconnected, syringe part was touching a stopper¿ during surgery does not meet criteria for reporting as a reportable malfunction since it was only issue with auto gas filling not with the cassette.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK, AUTO GAS FILL
• 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: 18866300
• MDR Text Key: 337354652
• Report Number: 1644019-2024-00427
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657510146
• UDI-Public: 00380657510146
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751014
• Device Lot Number: 160XFD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Date Device Manufactured: 08/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1