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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIDEX NIDEX OPHTHALMOLOGY LASER

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NIDEX NIDEX OPHTHALMOLOGY LASER Back to Search Results
Model Number GYC 1000
Event Type  Injury  
Event Description

While using the nidex diode laser, the pts are experiencing pain, when there should be none. The power output has been checked by in-house bmet and by nidex and are within specifications. The laser has been changed, and the dual delivery slit lamp/ indirect switch box has been changed. The pattern of the laser beam appears to concentrate the laser power towards the center of the beam, rather than be evenly distributed.

 
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Brand NameNIDEX
Type of DeviceOPHTHALMOLOGY LASER
Manufacturer (Section D)
NIDEX
47651 westinghouse drive
fremont CA 94539
MDR Report Key902835
Report NumberMW5003524
Device Sequence Number1
Product CodeHQF
Report Source Voluntary
Type of Report Initial
Report Date 07/20/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberGYC 1000
OTHER Device ID NumberGYC DUAL DELIVERY BOX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/31/2007 Patient Sequence Number: 1
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