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

Catalog Number 8065752438

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

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 blade could not be removed from trocar cannula during a procedure.The trocar cannula was bent.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

Additional information provided.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.One opened trocar handle/blade assembly with tip protector and one opened trocar hub/cannula assembly were received in a pouch.The returned cannula/hub assembly was visually inspected and was found non-conforming with a damaged tip of the cannula.A dimensional inspection for cannula inner diameter and a functional fit test could not be performed on the sample due to the cannula tip damage.The evaluation confirmed damage to the tip of the trocar.The sample was unable to be dimensionally of functionally tested, however, a damaged tip would contribute to product fit issues as was reported.The exact root cause for this complaint is unknown, however, a potential contributing factor related to the manufacturing process of the trocar cannula/hub assemblies has been identified.An investigation has been completed and manufacturing process enhancements have been implemented in order to reduce the frequency of trocar complaints for damaged cannula.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.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, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8132666
• MDR Text Key: 129448294
• Report Number: 1644019-2018-00277
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752438
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1