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

Model Number GX-770

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

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 tube head on the gx-770 fell off and struck a male patient in the shin.The unit was being prepared by the customer for clinical use on a patient when the tube head fell and it the male patient in the shin.There was no injury to the patient, nor any medical treatment administered.

• 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: al myers ; 1910 north penn road; hatfield, PA 19440 ; 2159975665
• MDR Report Key: 9226657
• MDR Text Key: 201688115
• Report Number: 2530069-2019-00006
• 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: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1989
• 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