MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GENDEX GX-770; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number GX-770

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured on 05-december-2005 and has been in the field for 10 years.The model was discontinued in march 2010.The customer stated that the device has been repaired by a service technician and refused to return the device for further investigation.No evaluation could be performed on the device.No injuries were reported.This concludes our investigation.Device not returned to manufacturer.

Event Description

The customer reported that the tube head became dislodged as the hygienist was positioning the device.The hygienist caught the tube head.There was no patient involvement and no injuries have been reported.

• Brand Name: GENDEX GX-770
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 w oakton st; des plaines IL 60018
• 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: 5317834
• MDR Text Key: 34132088
• Report Number: 2530069-2015-00009
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2005
• 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