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

Model Number 0.822.5214

Device Problem Device Fell (4014)

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

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation was conducted using interviews and examining three photos of the unit, lag bolts, and wall where it had been attached.It appears that the top bolt came out of the wall and the bottom bolt was bent from the weight of the unit.A root cause could not be determined; however, it appears that the unit had been moved since the initial installation.The re-install may have diminished the wall stud integrity to support the unit.Sales of the expert dc were discontinued on june 24, 2016.This concludes the investigation.

Event Description

It was reported that the unit fell off the wall.It was reported that unit was caught by the hygienist and hit the patient in the leg, but there was no injury reported for the patient or the operator (hygienist).Unit was reattached to the wall.

• Brand Name: GENDEX EXPERT DC
• Type of Device: EXTRAORAL 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: erika martin ; 1910 north penn road; hatfield, PA 19440
• MDR Report Key: 8638116
• MDR Text Key: 147340658
• Report Number: 2530069-2019-00004
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K996210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.822.5214
• Device Catalogue Number: EXPERT DC65 NA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1