MAUDE Adverse Event Report: GENDEX CORP. GENDEX GX-770; DENTAL EXTRA ORAL SOURCE X-RAY UNIT

Model Number GX-770

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/17/2014

Event Type  malfunction  

Event Description

The dental assistant was positioning the device to take x-ray on a patient when the tubehead became dislodged as the assistant was pulling it.The dental assistant caught the tubehead.Neither the dental assistant nor the patient received injury from this incident.

Manufacturer Narrative

The device was manufactured in january 2006 and was in service in the field for 8 years.The customer claimed that periodic maintenance was performed annually on the device.The device was returned to the manufacturer for evaluation on (b)(4) 2014.Based upon the visual inspection of the returned parts, the tubehead and yoke were received detached from the articulating arm.The cause of the detachment was attributed to the set screw disengagement whose function was to secure the pivot rod to the arm.There were impressions on the returned parts to suggest that the set screw was properly engaged previously.Although the exact cause fot he failure cannot be determined, a probable cause is human error for not ensuring proper positioning of the set screw during routine maintenance.This concludes the investigation for this incident.

• Brand Name: GENDEX GX-770
• Type of Device: DENTAL EXTRA ORAL SOURCE X-RAY UNIT
• Manufacturer (Section D): GENDEX CORP.; des plaines IL
• Manufacturer Contact: ruth pui ; 2800 crystal dr.; hatfield, PA 19440 ; 2679541479
• MDR Report Key: 4101966
• MDR Text Key: 4721146
• Report Number: 2530069-2014-00008
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• 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