MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GENDEX EXPERT DC; DENTAL EXTRA ORAL SOURCE X-RAY UNIT

Model Number EXPERT DC

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

The operator was positioning the x-ray tube head for a scan when the arm abruptly dropped.The operator was able to catch the arm assembly on time.No injuries have been reported.

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.Device not returned to manufacturer.

Manufacturer Narrative

The device was manufactured in march 2014 and is over a year old.The suspect device was received for evaluation on june 25, 2015.Visual inspection revealed that the articulated arm was missing the p-link pin.The set screw holding the p-link pin in place was loose, which likely contributed to the p-link becoming dislodged.A review of the device history record revealed that the articulated arm was assembled according to the established procedure and passed all functional tests.No patient injury was reported.The device operated within specification prior to failure.This concludes our investigation.

• Brand Name: GENDEX EXPERT DC
• Type of Device: DENTAL EXTRA ORAL SOURCE X-RAY UNIT
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): IMAGING SCIENCES INTERNATIONAL/ GENDEX/ DEXIS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 4856263
• MDR Text Key: 22026293
• Report Number: 2530069-2015-00003
• 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: Distributor
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXPERT DC
• Device Catalogue Number: 1.006.2581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• 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