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

Catalog Number 8065751058

Device Problem Blocked Connection (2888)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/26/2018

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 pharmacist reported that removal of infusion from the trocar was blocked with misfit trocar of the orange collar.It was reported that there is a possibility that the rest of the material was retained in the patient's eye.Additional information has been requested but not received to date.

Manufacturer Narrative

Additional information provided.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 indicates there are no additional complaints associated with the lot for the reported issue.One opened trocar cannula on an infusion cannula was received in a specimen container for evaluation.The returned sample was visually inspected and was found to be non-conforming.The hub of the trocar assembly is separated from the cannula, and there is a compressed area of the cannula with indentation marks.There was presence of adhesive inside of the hub.The cannula was then dimensionally measure for the inner diameter and was found to be non-conforming.The cannula measured 0.0263 inches when the pin gage entered the cannula, however due to the compressed area of the cannula, the pin gage could not pass completely through the cannula.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned sample identified adhesive inside of the hub, therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for the reported issue of broken hub is unknown.A potential contributing factor of the separation is manipulation during surgery, indicated by the indentation marks on the cannula where the body is compressed.The evaluation of the returned sample identified the cannula body is compressed, therefore how and when the cannula body became compressed cannot be determined from the evaluation and the root cause of the reported issue of product fit is unknown.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.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 7990048
• MDR Text Key: 124670992
• Report Number: 1644019-2018-00246
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 8065751058
• Device Lot Number: 2101100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1