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

Catalog Number 8065751900

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 03/07/2016

Event Type  Injury  

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)(6).

Event Description

A customer reported that the product leaked during a retinal procedure.A complication occurred and sutures were utilized.Additional information was requested; however, none has been received to date.This one of two patients.

Manufacturer Narrative

Additional information: three opened 23 ga trocar cannula/hub assemblies were received in a small parts tray.The returned samples were visually inspected.Sample 1 was found nonconforming with a hole in the septum.Samples 2 and 3 were found to be conforming.The device history record review indicated the product was released based on the product¿s acceptance criteria.However, 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.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.A non-safety medical device correction was completed on (b)(4) 2015 and a manufacturing change implemented to address the root cause.All potentially impacted customers have been contacted, trocar plugs made available and other risk mitigations discussed.(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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5534384
• MDR Text Key: 41430440
• Report Number: 1644019-2016-00591
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 8065751900
• Device Lot Number: 1780757H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 64 YR