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

Model Number 1.005.4517

Device Problem Component Falling (1105)

Patient Problem Contusion (1787)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

The device was manufacturer on may 19, 2014 and installed in september 2014.An on-site investigation by a qualified service technician revealed visual evidence that the office infrastructure failed and the area of the wall supporting the mounted device had crumbled due to aging, causing the device to become dislodged and fallen off the wall.The hardware used to mount the device to the wall was found to be still intact following the incident and the failure was determined to be not attributable to the device.This concludes the investigation.Device not returned to manufacturer.

Event Description

The operator was extending the device scissor arm when the complete unit abruptly fell off the wall.The operator sustained a contusion to the hand.No patient injury has been reported.

Manufacturer Narrative

The device was manufactured on may 14, 2014.

• Brand Name: GENDEX EXPERT DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn rd; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal dr; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 5033300
• MDR Text Key: 25007262
• Report Number: 2530069-2015-00005
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: 1.005.4517
• Device Catalogue Number: EXPERTDC75 WW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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