MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS 765 DC; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 765DC

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has been in use since (b)(6) 2005.The model was discontinued in august 2007.The device will not be returned to the manufacturer for further investigation as the device has already been scrapped by the dental office.No evaluation could be performed on the device.There were no serious injuries reported.The distributor confirmed that the lag bolts pulled out of the wall and was not related to the device itself.This concludes the investigation.

Event Description

It was reported that the x-ray fell off the wall and struck a patient.After contacting the dental office, it was reported that the patient is a (b)(6) male who received a scratch.There was no medical intervention reported.No other injries were reported.

• Brand Name: 765 DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): IMAGING SCIENCES INTERNATIONAL/GENDEX/DEXIS; 2800 crystal drive; hatfield PA 19440
• Manufacturer Contact: erika martin ; 2800 crystal drive; hatfield, PA 19440 ; 7045877241
• MDR Report Key: 7269261
• MDR Text Key: 100247230
• Report Number: 2530069-2018-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 765DC
• Device Catalogue Number: 0.820.0144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR