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

Catalog Number 8065751077

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

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 nurse reported the trocar cannula separated from its hub during a procedure.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation of the report of cannula detached from the product.However, two photos attached to the parent complaint were reviewed by the manufacturing site: photo 1 confirms the reported issue of a separated trocar cannula and hub.Photo 2 confirms the reported product and lot information of the custom pak.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.A complaint history examination for device component lots traceable to the reported lot number indicates there are no additional complaints associated with the component lots for the reported issue.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.Since no sample was received at the manufacturing, the sample could not be evaluated for adhesive, but the returned customer photo does confirm the reported issue of the trocar cannula separated from the trocar hub therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.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: 8910726
• MDR Text Key: 155181467
• Report Number: 1644019-2019-00131
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 8065751077
• Device Lot Number: 2230740H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1