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

Catalog Number 8065751077

Device Problem Failure to Cut (2587)

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

Event Date 04/13/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that the probe could not cut and the aspiration was working during surgery.The product was replaced and the surgery was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received, at the manufacturing site for evaluation.For the report of the probe would not cut and aspiration was working.Therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site.And the product was processed and released according to the product¿s acceptable criteria.Therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown.Therefore, specific action with regards to this complaint cannot be taken.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.No adverse trends have been observed, associated with the reported product and event.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: 11790211
• MDR Text Key: 249474289
• Report Number: 1644019-2021-00311
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657510771
• UDI-Public: 00380657510771
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065751077
• Device Lot Number: 2288311H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1