MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC

Catalog Number ASKU

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.The manufacturer internal reference number is: (b)(4).

Event Description

A theatre manager reported that the valved trocar leaked at the beginning of a vitrectomy procedure.The procedure was completed.There was no patient harm.No product sample is available for evaluation.

• Brand Name: VALVED ENTRY SYSTEM
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7902138
• MDR Text Key: 121710210
• Report Number: 2028159-2018-02018
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR