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

Model Number 1.006.2581

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer on 16-december-2016 and is undergoing evaluation.Upon completion of the evaluation, a follow-up report will be submitted.

Event Description

The customer reported that the device tubehead became dislodged from the articulated arm and was hanging by the wires during a patient scan.The tubehead did not make contact with the patient.No injuries have been reported.

Manufacturer Narrative

(b)(6).The unit was returned to the manufacturer on 16-december-2016 and the evaluation was completed on 22-march-2017.Visual inspection of the returned unit confirmed the reported symptom that the tube head had become dislodged from the articulated arm at the pivot joint assembly and was hanging by the electrical wires through the articulated arm.Visual inspection of the pivot joint assembly revealed material deformation on the inside of the pivot joint casting and material transfer on the pivot joint shaft.Based on the investigation and dhr review, the root cause of the failure was determined to be a compromised press fixture that resulted in the pivot shaft being slightly misaligned with the pivot casting during the pivot joint press process.No remedial action has been deemed necessary for the low risk of substantial harm to the public health this failure mode represents.This concludes our investigation.

• Brand Name: GENDEX EXPERT DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 6218433
• MDR Text Key: 63733443
• Report Number: 2530069-2017-00001
• 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: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: 1.006.2581
• Device Catalogue Number: EXPERTDC75 NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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