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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 06/28/2017
Event Type  Malfunction  
Manufacturer Narrative

No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified. A review of the device history record traceable to the reported lot number indicated that the product was processed and released according to the product¿s acceptance criteria. A complaint history examination indicated there are 7 additional complaints associated with the lot for the reported issue. No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined. The exact root cause for this complaint is unknown. Investigations have been completed and actions are presently being implemented in order to improve the performance of the valves. No additional action is required at this time. (b)(4).

 
Event Description

A nurse reported that a valved trocar leaked and the eye was unstable during a procedure. The procedure was completed and there was no harm to the patient. Additional information has been requested and received. This is one of two reports being filed for the same facility. (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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6747172
MDR Text Key81268299
Report Number1644019-2017-00625
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2017
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 Number8065751900
Device LOT Number1891185H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/09/2016
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: 07/27/2017 Patient Sequence Number: 1
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