MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS 765DC; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 765DC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2016

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 operator was moving the device x-ray tube head when the complete unit abruptly fell off the wall.The operator caught the device on its way down.No injuries have been reported.

Manufacturer Narrative

The initial reporter was identified as (b)(6) in and has been corrected to (b)(6).The unit was returned to the manufacturer on 09-february-2016.Visual inspection revealed a dislodged threaded insert inside the wall mounting plate.As a result of the dislodged insert, the full weight of the unit was left on the lower support bolt causing an imbalance in weight and ultimately leading to the unit falling off the wall.The returned wall mounting plate was determined to be in scope of recall number z-1559-2011.The recall was initiated by the manufacturer on 13-december-2010 and terminated by fda on 14-august-2012.As part of the recall, 33 of the 34 affected wall plates were retrieved prior to recall termination, and the retrieved 33 wall plates were properly dispositioned following termination of the recall.All required field communications and field actions from the manufacturer were verified to be effective.Corrective actions to mitigate the failure mode related to the wall mounting plate were successfully completed and verified during the recall and no further actions will be taken.This concludes our investigation.

• Brand Name: 765DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 w. oakton st.; des plaines IL 60018
• 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: 5409869
• MDR Text Key: 37442808
• Report Number: 2530069-2016-00002
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: 765DC
• Device Catalogue Number: 0.820.0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1559-2011
• Patient Sequence Number: 1