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

Model Number 1.006.2581

Device Problem Installation-Related Problem (2965)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

An on-site visit by a service technician revealed visual evidence that the wall backing material was not sufficient to support the full weight of the unit resulting in the lag bolts pulling out of the wall.The expert dc installation manual (032-0204-en) provides instructions for proper device mounting based on the installer's assessment of the condition of the wall.The malfunction was determined to be the result of an improper installation.This concludes our investigation.Device not returned to manufacturer.

Event Description

The operator was positioning the device for a scan when the complete unit abruptly fell off the wall.The operator caught the device and sustained swelling on the right hand and fingers.The device made contact with the patient but did not result in injury.No serious injury to the patient or operator has been reported.

• Brand Name: GENDEX EXPERT 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): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 5667703
• MDR Text Key: 45574876
• Report Number: 2530069-2016-00006
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.006.2581
• Device Catalogue Number: EXPERTDC75 NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2012
• 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