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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065490006
Device Problem Failure to fire
Event Date 03/15/2007
Event Type  Malfunction  
Event Description

A system operator reports the laser did not fire at the beginning of a procedure. The surgery was aborted, the system was rebooted and the surgeon was able to complete the surgery without further issue. The system operator reported the patient was not harmed or injured by this event.

 
Manufacturer Narrative

Reporting of this complaint at this time is based on receipt of a letter from the fda dated april 10, 2008 in which the agency informed alcon that complaint (event date: 2006) should have been reported as a serious injury mdr. As a result of that injury report, a 2-year reporting timeframe was initiated for all complaints of the same type. All complaint files for the ladarvision4000 were reviewed for this type of event starting 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: the field service engineer (fse) was dispatched to the site to evaluate the laser. The fse observed the laser not firing during surgery day performance testing and identified the event occurred by reviewing the surgery database. The fse replaced the thyratron and completed a system verification. During bench testing of the returned part, manufacturing found the thyratron would not pass the prefire testing. Conclusion: based on the results of the investigation, the root cause is component related, specifically the thyratron.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CTR
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1065593
Report Number1061857-2008-00087
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065490006
OTHER Device ID Number5.5.0, CSPS
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/29/2007
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/15/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/1999
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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