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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 8065751765
Device Problem Fluid Leak (1250)
Patient Problem No Code Available (3191)
Event Date 11/07/2016
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. (b)(4).

 
Event Description

An ophthalmic surgeon reported that a valved trocar leaked and the patient experienced two hypotonias during a left eye, vitrectomy procedure for a retinal and choriodal detachment. The surgeon tried to stop the fluid loss by using he finger and the procedure was continued normally. The procedure was completed and there was no harm to the patient. The product sample was retained. No additional information is expected.

 
Manufacturer Narrative

Two opened trocar cannula/hub assemblies were received in a zip top bag for the report of leaking. The returned samples were visually inspected and they were found to be conforming. The samples were functionally tested for leaking and they were conforming. A review of the device history records traceable to the reported lot number has been performed. The device history record review indicated that the product was processed and released according to the product¿s acceptance criteria. A complaint history examination indicated there were four additional complaints for the reported issue. A root cause cannot be determined for the complaint as described by the customer. No additional action is required at this time. (b)(4).

 
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Brand NameCONSTELLATION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL 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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6135881
MDR Text Key61494289
Report Number1644019-2016-01471
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device Catalogue Number8065751765
Device LOT Number1909560H
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/30/2016 Patient Sequence Number: 1
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