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

Catalog Number	8065751614
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
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 healthcare professional reported that there was no vacuum during vitrectomy surgery.The surgery was completed after replacing the vitrector with new one.There was no patient harm.
Additional Manufacturer Narrative
One opened probe was received, with a tip protector, in a bag, for the report.The sample was visually inspected and found to be nonconforming with white foreign material along the needle.The sample was then functionally tested for actuation and aspiration.The sample was found to be nonconforming for both functional test.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard pictures.Wear marks observed along the inner cutter.Gouge marks observed at several locations along the inner cutter.The sample was tested with a syringe and no resistance was felt.The sample was retested for actuation and aspiration with the probe driver and was able to actuate and aspiration.The initial actuation and aspiration tests failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate and aspirate.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 reported product was processed and released according to the reported product¿s acceptance criteria.The picture attached was reviewed by the manufacturing site.The picture shows a pak label with same product and lot number as reported.The complaint evaluation confirms the event, the evaluation also indicates the probe had an actuation failure.The exact cause of the actuation and aspiration failures cannot be determined from the evaluation performed.No action has been taken by the manufacturing site as an exact root cause for the actuation and aspiration failures could not be determined from this evaluation.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.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 PACK
• 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: 19688955
• Report Number: 1644019-2024-01487
• Device Sequence Number: 12746695
• Product Code: LRO
• UDI-Device Identifier: 00380657516148
• UDI-Public: (01)00380657516148(17)250228(11)230314(10)15E084(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 02/28/2025
• Device Catalogue Number: 8065751614
• Device Lot Number: 15E084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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