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

Model Number GX-770

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation at the time of this report.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

The customer reported that the device scissor arm spring popped and the scissor arm began to dangle as it was being positioned back against the wall by the dental assistant.No injury to the dental assistant or patient was 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 ; 2679540338
• MDR Report Key: 5644662
• MDR Text Key: 44891522
• Report Number: 2530069-2016-00005
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K935046
• 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: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2000
• 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