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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDER DENTAL SYSTEMS GX-770; EXTRAORAL SOURCE X-RAY SYSTEM
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GENDER DENTAL SYSTEMS GX-770; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number GX-770
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2014
Event Type  malfunction  
Event Description
The tube head of the device came out of the yoke as it was being placed back to the wall after taking an x-ray scan.The tube head was caught by the operator and no injury was reported.
 
Manufacturer Narrative
The device is over (b)(6) and was discontinued in 2010.Our initial investigation concluded that this device has not received periodic annual maintenance as recommended in the user manual.The device is beyond end of life.
 
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Brand Name
GX-770
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDER DENTAL SYSTEMS
901 west oakton st
des plaines IL 60018 188
Manufacturer Contact
martin rajchel
1910 north penn rd.
hatfield, PA 19440
2679540338
MDR Report Key4014078
MDR Text Key4880725
Report Number2530069-2014-00006
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGX-770
Device Catalogue Number0.820.0146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/1986
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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