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

Catalog Number	8065751561
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the probe aspirated but failed to cut the vitreous during vitrectomy surgery.The surgery was completed after replacing with another pack.There was no harm to patient.
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).
Additional Manufacturer Narrative
One opened probe was received with a tip protector, in a pouch, for the report.The sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and the port orientation non-conforming and facing the wrong way.The sample was then functionally tested for actuation and cut.The sample was found to be non-conforming for actuation.The cut functionality of the probe was unable to be tested due to the actuation failure.The probe sample was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at a couple locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.The needle holder and retainer were then disassembled and components inspected.All components were observed to be conforming.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation indicates that the probe had an actuation failure.The cut functionality of the probe was unable to be tested due to the actuation failure.The exact root cause for the actuation failure cannot be determined from the evaluation performed.The evaluation also indicated that the needle port orientation was non-conforming.The cause of the non-conforming port orientation is due to the port positioning process during the probe manufacturing process.A non-conformance investigation was initiated in order to investigate the root cause of the non-conforming needle port orientation.The exact root cause of the actuation failure could not be determined, therefore, no specific action with regard to this complaint was taken by 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.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: 16974248
• Report Number: 1644019-2023-00595
• Device Sequence Number: 14066718
• Product Code: LRO
• UDI-Device Identifier: 00380657515615
• UDI-Public: 00380657515615
• 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
• Report Date (Section B): 09/16/2023

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
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 09/16/2023
• 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