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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB TECHNOLAS EXCIMER 217A LASER EXCIMER LASER

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BAUSCH & LOMB TECHNOLAS EXCIMER 217A LASER EXCIMER LASER Back to Search Results
Catalog Number EXC-217A
Device Problem Fire
Event Date 10/18/2007
Event Type  Malfunction  
Event Description

During a regular repair visit, the field service engineer opened the laser head containment cover and found one of the cables was burning. He closed the cover and the fire was extinguished. There were no patients present at the time, and there were no injuries to the engineer or the facility staff.

 
Manufacturer Narrative

The fire was caused by the improper mounting of the high voltage cable to the laserhead during a previous field service.

 
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Brand NameTECHNOLAS EXCIMER 217A LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
BAUSCH & LOMB
rochester NY 14609
Manufacturer Contact
janet lacavich,
3365 tree ct. industrial blvd.
st. louis , MO 63122
6362263213
MDR Report Key949589
Report Number1920664-2007-01427
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 10/18/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEXC-217A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received10/18/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/16/2007 Patient Sequence Number: 1
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