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

Catalog Number 8065751765

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

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

Event Date 08/23/2021

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 pharmacist reported a cassette was damaged and while connecting it to the machine, the water entered the cassette spilled into the floor during calibration for a vitrectomy procedure.There was no patient involvement.

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 unused combined procedure pak was visually inspected and it was observed that the infusion chamber walls of the pinch plate were cracked.The sample was tested using a calibrated console representing the current software version and system message code 3202 occurred.The cracked infusion chamber walls of the pinch plate appeared that the damage occurred during the infusion chamber welding process.The likely root cause of the customer's complaint is related to the infusion chamber welding process.The source of this defect is related to an error in the welding process during manufacturing.This complaint has been reviewed and it is determined that no further actions will be pursued at this time.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• 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: 12565203
• MDR Text Key: 274442526
• Report Number: 1644019-2021-00601
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517657
• UDI-Public: 00380657517657
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 8065751765
• Device Lot Number: 2458974H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1