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

Model Number GX-770

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

The tubehead of the device came off as the hygienist was positioning the device for x-ray.The hygienist caught the tubehead, it did not hit the pt.There was no injury associated with this incident.

Manufacturer Narrative

The investigation of the returned gx-770 was completed on (b)(4) 2014.The model was discontinued in march 2010, and this device has been in use in the field for more than 11 years.The inspection of the device showed that although the tube head broke apart from the articulating arm and the wires were broken as a result, the unit was mechanically functional.The root cause of this failure could not be determined as all parts received were in good mechanical condition.This concludes our investigation.

• Brand Name: GX-770
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 west oakton st.; des plaines IL 60018 188
• Manufacturer (Section G): IMAGING SCIENCES INTERNATIONAL/GENDEX/DEXIS; 1910 north penn rd.; hatfield PA 19440
• Manufacturer Contact: ruth pui ; 2800 crystal dr.; hatfield, PA 19440 ; 2679541479
• MDR Report Key: 3820223
• MDR Text Key: 4446896
• Report Number: 2530069-2014-00005
• 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: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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