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

Catalog Number 8065751155

Device Problems Defective Component (2292); Suction Failure (4039); Air/Gas in Device (4062)

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

Event Date 11/14/2022

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 aspiration failure occurred during ultrasound, bubbles were found to be mixed in due to the poor shape of the aspiration connector.There was a possibility of a defect with the aspiration connector.The surgery was completed after replacing the product with another one.There was no report of a patient harm.The sample was discarded.Additional information received from the company representative who indicated that the sample is available to be returned.

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 confirmed, the blue aspiration fitting was deformed.The deformed connector resulted in customer experience.After an analysis.And based on the condition of the sample, the root cause is potentially related to an error, during the suppliers manufacturing process of the aspiration connector.After an investigation of this complaint.It has determined, that no further actions will be pursued at this time.The supplier has been made aware of the issue.No adverse trends have been observed, associated with the reported product and event.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: 15930693
• MDR Text Key: 307577277
• Report Number: 1644019-2022-01023
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10380657511553
• UDI-Public: 00380657511556
• 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,Followup
• Report Date: 04/27/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 8065751155
• Device Lot Number: 14F1T8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/27/2023
• Date Device Manufactured: 04/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM