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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752917
Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2017
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

A customer reported that the sleeves have been variable during procedures. It was reported that the sleeves are different colors, that they do not go through the incision very smoothly and that they rip easier. There was no report of patient harm.

 
Manufacturer Narrative

This is the fourth complaint reported for this finished goods lot; however the third for this issue. Review of the device history record indicates the order was built to specification. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted. The root cause of the customer's complaint could not be established as a sample has not been received. Without a sample, it is not possible to isolate the root cause. After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned. Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary. (b)(4).

 
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Brand NameCENTURION 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 Key6455039
MDR Text Key71700678
Report Number1644019-2017-00311
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue Number8065752917
Device LOT Number1972953H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2017
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: 04/03/2017 Patient Sequence Number: 1
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