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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON-ORLANDO TECHNOLOGY CENTER LADARVISION 4000

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ALCON-ORLANDO TECHNOLOGY CENTER LADARVISION 4000 Back to Search Results
Catalog Number 8065490006
Device Problem Failure to fire
Event Date 11/07/2007
Event Type  Malfunction  
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 were reviewed for this type of event starting 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation, the territory manager, (tm) performed a complete diagnostics and found no problem with the system; however, the tm did confirm the event as reported in the surgery database. The tm completed successful system verification. No parts were replaced or returned for eval. Conclusion: based on the investigation and the results of prior investigations, the event was consistent with normal behavior of the thyratron technology and the root cause is most likely related to the thyratron.

 
Event Description

A system operator reports the system displayed the message, "laser not firing" at 75% into a procedure. The system operator backed out of the surgery screen, re-entered and the surgeon was able to proceed. During follow-up, the system operator stated the pt was doing great and there was no harm or injury.

 
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Brand NameLADARVISION 4000
Type of DeviceLADARVISION
Manufacturer (Section D)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer (Section G)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1074097
Report Number1061857-2008-00144
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/07/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2008
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
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/07/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/14/2000
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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