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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK CONVENIENCE KIT

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ALCON - HOUSTON CUSTOM PAK CONVENIENCE KIT Back to Search Results
Model Number CUSTOM PAK
Device Problems Probe; Fitting Problem; Device Issue
Event Date 01/22/2015
Event Type  Malfunction  
Event Description

A surgeon reported unable to insert the probe cutter through the trocar valve and suspected "clogging of the trocar valve". The procedure was completed without consequence to the patient. A product sample has been requested for this report. This is the second of two reports for the event. This report will address the trocar valve.

 
Manufacturer Narrative

Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in according with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).

 
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Brand NameCUSTOM PAK
Type of DeviceCONVENIENCE KIT
Manufacturer (Section D)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
janet moran
6201 south freeway
r3-48
fort worth , TX 76134
8176152742
MDR Report Key4535792
Report Number1644019-2015-00019
Device Sequence Number1
Product CodeKYG
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL NumberCUSTOM PAK
Device Catalogue NumberCUSTOM PAK
Device LOT Number1677454H
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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