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

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.

• Brand Name: GAMMA NAVIGATION PROBE 2.0
• Type of Device: PROBE, UNTAKE, NUCLEAR
• Manufacturer (Section D): DILON TECHNOLOGIES, INC.; 12050 jefferson ave ste. 340; newport news VA 23606
• MDR Report Key: 7984036
• MDR Text Key: 124308927
• Report Number: 7984036
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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 FDA: 10/04/2018
• Date Report to Manufacturer: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1