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U.S. Department of Health and Human Services

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

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GENDEX DENTAL SYSTEMS GENDEX EXPERT DC EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 1.006.2581
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer on 16-december-2016 and is undergoing evaluation. Upon completion of the evaluation, a follow-up report will be submitted.
 
Event Description
The customer reported that the device tubehead became dislodged from the articulated arm and was hanging by the wires during a patient scan. The tubehead did not make contact with the patient. No injuries have been reported.
 
Manufacturer Narrative
(b)(6). The unit was returned to the manufacturer on 16-december-2016 and the evaluation was completed on 22-march-2017. Visual inspection of the returned unit confirmed the reported symptom that the tube head had become dislodged from the articulated arm at the pivot joint assembly and was hanging by the electrical wires through the articulated arm. Visual inspection of the pivot joint assembly revealed material deformation on the inside of the pivot joint casting and material transfer on the pivot joint shaft. Based on the investigation and dhr review, the root cause of the failure was determined to be a compromised press fixture that resulted in the pivot shaft being slightly misaligned with the pivot casting during the pivot joint press process. No remedial action has been deemed necessary for the low risk of substantial harm to the public health this failure mode represents. This concludes our investigation.
 
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Brand NameGENDEX EXPERT DC
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
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
martin rajchel
2800 crystal drive
hatfield, PA 19440
2679540338
MDR Report Key6218433
MDR Text Key63733443
Report Number2530069-2017-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Service Personnel
Type of Report Initial,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dental Assistant
Device Model Number1.006.2581
Device Catalogue NumberEXPERTDC75 NA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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