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

Model Number GX-770

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned to the manufacturer for evaluation.A cause as to the malfunction of the unit component cannot be determined.The gx-770 was discontinued from sale on (b)(6) 2010 and the manufacturer support of the device ended on (b)(6) 2017.This concludes the investigation.

Event Description

It was reported that the gx-770 tubehead broke loose and fell off the shaft and was hanging by its wires.The hygienist was wiping down the device when the device came apart and the unit fell against the wall and was laying on the counter top.There was no report of operator or patient injury.

• Brand Name: GX-770
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• 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: erika martin ; 1910 north penn road; hatfield, PA 19440
• MDR Report Key: 8601450
• MDR Text Key: 145776169
• Report Number: 2530069-2019-00003
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2005
• 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