MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GENDEX GX-770; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number GX-770

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/13/2015

Event Type  malfunction  

Event Description

The tube head of the device became dislodged as the hygienist was positioning it in preparation for an x-ray scan.The hygienist caught the tube head.No patient or operator injuries were reported.

Manufacturer Narrative

The device is over 25 years old and was discontinued in 2010.The device is beyond end of life and was not returned for further investigation.The technician who visited the office concluded that the rotation stop was worn down to the point where the tube head could be rotated 360 degrees, causing the tube head to become loose.This concludes our investigation to a wear and aging issue.If additional information is obtained at a later time, a follow up report will be sent.

• Brand Name: GENDEX GX-770
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn rd.; des plaines IL
• Manufacturer Contact: martin rajchel ; 1910 north penn rd.; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 4528074
• MDR Text Key: 5409364
• Report Number: 2530069-2015-00001
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1989
• 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