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

Model Number 765DC

Device Problem Material Fragmentation (1261)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

The customer reported hearing a snap in the articulating arm and the tube head assembly dropped suddenly towards the ground.No injuries were reported.

Manufacturer Narrative

The device was manufactured in 2003 and discontinued in 2007.The device has been in use for 11 years.After the reported incident of the articulated arm dropping, the device was removed from the installed location and scrapped by the dealer technicians, making the device unavailable for further evaluation.There were no reported injury related to this incident.This concludes our investigation.

• Brand Name: 765DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 west oakton st.; des plaines IL 60018 188
• Manufacturer Contact: martin rajchel ; 1910 north penn rd.; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 4188328
• MDR Text Key: 19295782
• Report Number: 2530069-2014-00009
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1