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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
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).
 
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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 Key5534384
MDR Text Key41430440
Report Number1644019-2016-00591
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880961
Number of Events Reported1
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 Date01/31/2017
Device Catalogue Number8065751900
Device Lot Number1780757H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/07/2016
Initial Date FDA Received03/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age64 YR
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