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

Catalog Number 8065752450

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2020

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 the probe could no actuate during a procedure.Aspiration functionality is unknown.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray, for the report of actuation failure during surgery.The returned sample was visually inspected and found to be non-conforming with the needle slightly bent, white foreign material on the port, and orange/brown foreign material on the cap.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for actuation and aspiration and was non-conforming for cut.The probe was disassembled and the components inspected.Nominal 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 the cutting edge and one other locations along the inner cutter.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation did not confirm that the probe had an actuation failure.Unrelated to the reported event, the evaluation indicated that the probe had a cut failure.The cause for the poor cutting is the observed damage/wear to the inner cutter of the probe.A damaged/worn inner cutter can decrease the quality of the cut performed by the probe.How and when the inner cutter of the probe became damaged cannot be determined form this evaluation.The reported actuation failure was not confirmed and the exact root cause for the cut failure cannot be determined from the evaluation performed, therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% 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 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: 10033015
• MDR Text Key: 190317688
• Report Number: 1644019-2020-00244
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 8065752450
• Device Lot Number: 2342117H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION LXT JAPAN,; CONSTELLATION LXT JAPAN,