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

Model Number 765DC

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured on 24-march-2003 and has been in the field for over 13 years.The model was discontinued in august 2007.The device will not be returned to the manufacturer for further investigation as the customer has elected to keep it.No evaluation could be performed on the device.No injuries have been reported.This concludes our investigation.Device not returned.

Event Description

The customer reported that the scissor arm spring broke and the tube head dropped down during a patient x-ray scan.The tube head made contact with the patient's right shoulder but did not result in injury.No serious injury to the patient or operator has 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: 6283337
• MDR Text Key: 65957213
• Report Number: 2530069-2017-00004
• 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: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 765DC
• Device Catalogue Number: 0.820.0144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2003
• 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
• Patient Age: 54 YR