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

Model Number 1.005.4517

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation at time of this report.Upon completion of the evaluation, a follow-up report will be submitted.

Event Description

The customer reported that the device tube head became dislodged from the scissor arm while the x-ray unit was not in use.No injuries have been reported.

Manufacturer Narrative

After the reported incident of the tubehead becoming dislodged from the scissor arm, the device was removed from the doctor's office and the scissor arm was scrapped by the device dealer in (b)(4).The tubehead was returned from the dealer in (b)(4) to the manufacturer for evaluation; however, both the yoke and pivot joint components (both part of the device scissor arm) are needed to determine a root cause of the failure.The device history record was reviewed and did not contain any evidence pointing to the unit's failure and no issues were identified in the final or in-process inspections that were related to or that could affect the reported failure.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: 5973074
• MDR Text Key: 55463734
• Report Number: 2530069-2016-00011
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: 1.005.4517
• Device Catalogue Number: EXPERTDC75 WW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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