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

Model Number 765DC

Device Problem Material Fragmentation (1261)

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

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The customer reported that the articulating arm dropped suddenly towards the ground with no prior symptoms.No injuries were reported.

Manufacturer Narrative

The device was manufactured during 10/2002 and has been in the field for 12 years.The articulated arm of the 765dc was returned to the manufacturer for eval on 12/04/2014.Eval of the returned part was completed and the root cause of the failure was determined to be component wear, especially the two rotation stops above the horizontal arm being bent and partially sheared.The failure was found not to be 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.No maintenance records could be located for this device.This concludes our investigation.

• Brand Name: 765DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDER DENTAL SYSTEMS; des plaines IL
• Manufacturer Contact: martin rajchel ; 1910 north penn rd.; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 4340254
• MDR Text Key: 5140985
• Report Number: 2530069-2014-00011
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• 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?: Yes
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2002
• 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