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

Catalog Number 8065752452

Device Problems Decrease in Suction (1146); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

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 customer reported that actuation failure of the probe occurred during a procedure.The aspiration efficiency was poor.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received with a tip protector, in a bubble bag, for the report of actuation failure.The returned sample was visually inspected and found to be non-conforming with the tip and the port of the probe needle damaged and orange/brown foreign material on the port face.Functional testing was unable to be performed due to the visual condition of the probe.The probe 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.No wear marks were observed along the inner cutter.No lot number was identified with this complaint; however, a review of the device history records traceable to the lot number obtained from the customer returned device¿s rfid tag indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint sample was received with the port and tip of the needle damaged.Therefore, the an actuation failure was unable to be determined and the exact root cause of the complaint could not be verified.The exact root cause of the damaged tip and port cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site.The reported complaint issue was unable to be determined and an exact root cause could not be verified, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformance's found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.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
• MDR Report Key: 9972785
• MDR Text Key: 188344884
• Report Number: 1644019-2020-00210
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752452
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION LXT JAPAN,