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

Catalog Number 8065751617

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2019

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

Event Description

A nurse reported the surgeon found the trocar blade was hard to remove from the trocar cannula after creating the sclera incisions during a procedure.The trocar cannula worked fine and was not replaced however the trocar blade had an oxidized-like mark.There was no harm to the patient.

Manufacturer Narrative

Additional information provided in d.10., g.1., g.2., h.3., h.6., and h.10.One opened trocar assembly was received in a small parts tray for the report of hard to remove cannula from trocar blade.The sample was visually inspected and was found to be non-conforming for foreign material in the inner diameter (id) of the cannula.The trocar cannula was cleaned of the foreign material before dimensional and functional testing was performed.The trocar cannula was then dimensionally inspected for cannula inner diameter and was found conforming.A functional fit test with the blade/handle assembly was performed and was found to be conforming.A photo of the product is attached to the parent file and has been reviewed by the manufacturing site.The photo shows the trocar blade handle assembly.No issues to could be seen which could contribute to the reported issue of a trocar cannula hard to remove from the trocar blade.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 returned sample was found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and 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: 9304974
• MDR Text Key: 180414371
• Report Number: 1644019-2019-00172
• 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: 02/12/2020

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: 07/31/2020
• Device Catalogue Number: 8065751617
• Device Lot Number: 2185336H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 10/19/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1