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

Model Number 765 DC

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

The dental assistant was moving the arm of the x-ray machine from the pass-through cabinet to position and the arm dropped suddenly.The dental assistant caught the arm and put it back into the cabinet.The casting of the main converter box was found to be fractured so the arm fell.No staff or pt was injured during the incident.

Manufacturer Narrative

This unit was manufactured in 03/2001 and has been in the field for over 12 years.The model was discontinued in august 2007.The converter casting housing of the 765 dc was returned to manufacturer for evaluation on (b)(4) 2014.Evaluation of the returned part was completed and the root cause of this failure was determined to be improper installation.The top lag bolt was over stressed and broke the wall-mounted converter housing.This failure is not caused by a fault in the design or manufacture of the 765 dc.There was no injury from this incident, and this was an isolated incident.This concludes our investigation.

• Brand Name: GENDEX 765 DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX CORPORATION; 901 west oakton street; des plaines IL 60018 188
• Manufacturer Contact: ruth pui ; 1910 north penn rd.; hatfield, PA 19440 ; 2679541479
• MDR Report Key: 3932820
• MDR Text Key: 4602185
• Report Number: 2530069-2014-00002
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 765 DC
• Device Catalogue Number: 0.820.0925
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• 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