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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON LEGACY SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065750517
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
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. The manufacturer internal reference number is: (b)(4).

 
Event Description

A facility reported that the sleeve was twisting during the irrigation-aspiration step of a cataract procedure. The procedure was completed. There was no patient harm reported. According to the surgical equipment manager, it was determined that the surgeon was inadvertently winding the irrigation sleeve too far distally and causing the sleeve to bunch up behind the flared part of the polymer tip. A short in-service resolved the issue with no further incidents so far. This is one of three reports received from this facility.

 
Manufacturer Narrative

There have been no additional complaints reported against the finish goods lot and the device history record shows the product was released per specifications. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted. If a sample is returned at a later date, the investigation will be reopened and the sample evaluated. The surgical account manager stated that the surgeon was inadvertently winding the irrigation sleeve too far distally and caused the sleeve to bunch up behind the flare part of the polymer tip. After a short in service the issue was resolved. The root cause of the customer's complaint was caused by the surgeon inadvertently winding the irrigation sleeve to far on the polymer tip cause the sleeve to twist or bunch up on the tip. The issue was resolved after a short in service was done with the surgeon. After a thorough investigation of this complaint, it has been determined that no action will be taken at this time. 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. Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting. (b)(4).

 
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Brand NameLEGACY 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 Key7365871
MDR Text Key103526902
Report Number1644019-2018-00065
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device Catalogue Number8065750517
Device LOT Number2070606H
OTHER Device ID Number380657505173
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 Received05/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2017
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: 03/23/2018 Patient Sequence Number: 1
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