MAUDE Adverse Event Report: GENDEX GENDEX EXPERT DC; DIGITAL DENTAL X-RAY UNIT

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 12/17/2015

Event Type  Injury  

Event Description

Dental x-ray unit tube head leaking insulating oil.This is the 2nd dental unit of same manufacturer that has same problem within 1 1/2 years.Same manufacturer and lot.Leaking coolant oil from x-ray tube head on two gendex expert dc dental x-ray units.This oil surrounds the x-ray tube (heats up) to keep it within an operating range.The gasket / seal failed.I do not know how much oil is contained in the unit, nor do i know how much oil leaked out of the 2 units.Thus, i had to discontinue use for fear it would expose the patients to overdosed radiation.Dates of use: (b)(6) 2008.Reason for use: dental pathology/x-ray.

• Brand Name: GENDEX EXPERT DC
• Type of Device: DIGITAL DENTAL X-RAY UNIT
• Manufacturer (Section D): GENDEX
• MDR Report Key: 5612222
• MDR Text Key: 43873818
• Report Number: MW5061912
• Device Sequence Number: 2
• Product Code: EHD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention