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

Model Number GX-770

Device Problem Inadequate Service (1564)

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

Event Date 08/15/2014

Event Type  malfunction  

Event Description

The doctor was positioning the device to take x-ray on a patient when the horizontal arm, the articulated arm and the tube head became dislodged from the converter.The doctor caught the device in his arms.Neither the doctor nor the patient received injury from this incident.

Manufacturer Narrative

The device was manufactured in august 1002 and was in service in the field for 22 years.The customer indicated that a drifting of the arm assembly was noticed several weeks prior to the incident, along with a small crack in the assembly, which was ignored.The technician claimed that the unit was serviced periodically although there was no documented evidence found for maintenance.The device was returned to the manufacturer for evaluation on (b)(4) 2014.It was noticed that the horizontal arm was broken at the inner pivot housing, which caused the unit to separate from the horizontal arm to the main converter.The likely cause of the failure was the prolonged service of the unit beyond the end of the life.This concludes the investigation related to 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: 4101965
• MDR Text Key: 4756653
• Report Number: 2530069-2014-00007
• 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: 08/15/2014

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: 09/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1992
• 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