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

Model Number GX-770

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

Patient Problems Abrasion (1689); Erythema (1840)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured in march of 1991 and has been in the field for over 25 years.The model was discontinued in march of 2010.The device will not be returned to the manufacturer for further evaluation because the customer re-attached the tube head and elected to keep the device.The customer indicated that the device had not been maintained in accordance with the device labeling.The gx-770 user manual (415-0169) states that in the interest of equipment safety, a maintenance program must be established by the device owner and periodic maintenance performed by fully qualified personnel on an annual basis.This concludes our investigation.

Event Description

The operator was positioning the device for a scan when the tube head became dislodged and fell on the patient.The patient sustained a cut to the upper lip and redness of the skin (erythema) where the tube head made contact.The patient did not seek medical attention and no serious injury has been reported.

• Brand Name: GX-770
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 west oakton street; des plaines IL 60018 1884
• Manufacturer (Section G): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2159540338
• MDR Report Key: 6388452
• MDR Text Key: 69399864
• Report Number: 2530069-2017-00007
• 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: user facility
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/1991
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR