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

Model Number 765DC

Device Problems Device Maintenance Issue (1379); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

Photos provided from the office revealed visual evidence that maintenance had been performed on the device that was not in accordance with product labeling.A plastic piece had been cut away between the yoke and tubehead, wires showed solder residue, and the tubehead was not properly secured to the yoke.The 765dc user manual (g0112-99u) states that in the interest of equipment safety, a maintenance program must be established by the owner and service performed by fully qualified personnel on an annual basis.The equipment must only be installed and operated in accordance with the safety procedures and operating instructions given in the user manual and installation/maintenance manual for the purposes and applications for which it was designed.Modifications and/or additions to the equipment may only be carried out by gendex or by third parties expressly authorized by gendex to do so.The device was not returned to the manufacturer for further evaluation and was scrapped by the service company.This concludes our investigation.

Event Description

A service technician observed a 1/2" separation between the device tubehead and yoke during a service call.It was also observed that only one screw and locking nut was used to secure the tube head to the yoke.The tubehead did not become fully dislodged from the device and no injuries have been reported.

• Brand Name: 765DC
• 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: 5869564
• MDR Text Key: 51936815
• Report Number: 2530069-2016-00010
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 765DC
• Device Catalogue Number: 0.820.0331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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