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

Catalog Number	8065751561
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A physician reported that product got clogged during surgery.The surgery was successfully completed after replacing the product with another one.There was no patient harm.The procedure type was unknown.
Additional Manufacturer Narrative
One opened probe was received.However, the reported lot number was expired when the sample was received at the manufacturing site.Therefore, no product evaluation was performed due to the reported functional issue.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was returned and the device history record review of the lot number obtained from the device¿s radio frequency identification tag indicated the product was processed and released according to the product¿s acceptable criteria.However, when the sample was received at the manufacturing site it was determined that the device was beyond its expiry date; therefore, a root cause was unable to be determined.No specific action with regard to this complaint was taken by the manufacturing location because the complaint sample exceeded its expiration date when the sample was received at the manufacturing site.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).
Additional Manufacturer Narrative
Corrected information was updated in d4.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION ULTRAVIT PROBE PROCEDURE PAK
• Common Device Name: 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: 19141576
• Report Number: 1644019-2024-00762
• Device Sequence Number: 20684236
• Product Code: LRO
• UDI-Device Identifier: 00380657515615
• UDI-Public: (01)00380657515615(17)240331(11)220407(10)14F7FC(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 8065751561
• Device Lot Number: 14F7FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/26/2024; 08/23/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.
• Patient Sex: Unknown