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

Catalog Number 8065752022

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

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 when the infusion cannula was inserted into the trocar, it would fall down all the time without being self-standing during a procedure.The procedure was completed while supporting it with his finger until the end (without product replacement).There was no harm to the patient.

Manufacturer Narrative

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.Only the used infusion cannula line was returned.It was noted the trocar was returned for evaluation.The infusion cannula tip was measured by inserting the 25 gauge (ga) into the go-no-go gauge and confirmed the cannula tip to be 25ga.The infusion cannula tip was then inserted into a 25ga trocar and could fully engage together with no anomalies observed.It was confirmed 25ga trocars and 25ga infusion cannula was built into this finished goods lot.A review of the lot history indicates this issue to be an isolated event for this finished goods lot.The root cause of the customer's complaint could not be established as the returned met specifications.After investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective 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: 10155472
• MDR Text Key: 195538307
• Report Number: 1644019-2020-00295
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 8065752022
• Device Lot Number: 2312363H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM