MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS 765DC; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 765DC

Device Problem Detachment Of Device Component (1104)

Patient Problem Discomfort (2330)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured on 28-mar-2001 and has been in the field for over 14 years.The model was discontinued in august 2007.Based on an evaluation of similar reported failures related to 765dc, the root cause of the failure is most likely attributed to component wear.It is unlikely that the failure is the result of a manufacturing error.The 765dc installation/maintenance manual (g0112-99i) indicates that annual maintenance of the articulated arm is required to ensure proper operation.Additionally, the 765dc user manual (g0112-99u) indicates that a maintenance program must be established and recommends maintenance to be performed annually.This concludes our investigation.

Event Description

The customer reported that the device's articulated arm dropped towards the ground and made contact with the patient's face.No injuries were reported.

• Brand Name: 765DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 w oakton st; des plaines 60018
• 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 Key: 5295623
• MDR Text Key: 33455907
• Report Number: 2530069-2015-00008
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 765DC
• Device Catalogue Number: 0.820.0144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2001
• 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