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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DILON TECHNOLOGIES, INC. GAMMA NAVIGATION PROBE 2.0 PROBE, UNTAKE, NUCLEAR

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DILON TECHNOLOGIES, INC. GAMMA NAVIGATION PROBE 2.0 PROBE, UNTAKE, NUCLEAR Back to Search Results
Device Problem Fire (1245)
Patient Problem No Information (3190)
Event Date 08/13/2018
Event Type  Malfunction  
Event Description

While tightening screw on the back of the unit, the machine caught fire. The fire was extinguished.

 
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Brand NameGAMMA NAVIGATION PROBE 2.0
Type of DevicePROBE, UNTAKE, NUCLEAR
Manufacturer (Section D)
DILON TECHNOLOGIES, INC.
12050 jefferson ave ste. 340
newport news VA 23606
MDR Report Key7984036
MDR Text Key124308927
Report Number7984036
Device Sequence Number1
Product Code IZD
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2018
Event Location No Information
Date Report TO Manufacturer10/19/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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