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

Catalog Number 8065752437

Device Problem Failure to Cut (2587)

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

Event Date 04/06/2021

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 doctor reported that the probe did not cut and dragged vitreous during a procedure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the cutter was not working and it was dragging the vitreous; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened probe was received, with a tip protector, in a tray along with other items.The sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for both functional test.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore a cut failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 11688828
• MDR Text Key: 247279864
• Report Number: 1644019-2021-00274
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524372
• UDI-Public: 380657524372
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 03/17/2022

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: 04/30/2021
• Device Catalogue Number: 8065752437
• Device Lot Number: 2275739H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 07/01/2021; 03/01/2022
• Supplement Dates FDA Received: 07/02/2021; 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male