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

Catalog Number 8065830048

Device Problems Failure to Cut (2587); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

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.(b)(4).

Event Description

A customer reported that a strange sound was heard and the inner cutter seemed not actuating with poor cutting.The condition of aspiration is unknown.The procedure was completed without product replacement.There was no patient harm.

Manufacturer Narrative

The returned sample was visually inspected and found to be non-conforming with the probe needle completely broken off of the probe assembly, confirming the received condition of the probe.Functional testing, disassembly activities, and a wear evaluation were unable to be performed due to the visual condition of the probe.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 sample was received with the needle completely broken off of the probe assembly.Therefore, a confirmation of the reported event could not be determined and the exact root cause of the complaint could not be verified.The exact root cause of the broken needle 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.Confirmation of the reported event could not 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-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 PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11164212
• MDR Text Key: 227821482
• Report Number: 1644019-2021-00033
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 8065830048
• Device Lot Number: 2318852H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM