MAUDE Adverse Event Report: DILON TECHNOLOGIES, INC. NAVIGATOR; PROBE, UPTAKE, NUCLEAR

Device Problem Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 12/07/2018

Event Type  malfunction  

Event Description

Navigator stopped calibrating during the procedure and the surgeon could not find the cancer lymph nodes with the guidance of the navigator.

• Brand Name: NAVIGATOR
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): DILON TECHNOLOGIES, INC.; 12050 jefferson ave ste. 340; newport news VA 23606
• MDR Report Key: 8280963
• MDR Text Key: 134210218
• Report Number: 8280963
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA