MAUDE Adverse Event Report: MARUS LUXSTAR ORBIT MOUNT LIGHT; DENTAL OPERATING LIGHT

Model Number OL1000

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Burn(s) (1757)

Event Date 07/31/2014

Event Type  malfunction  

Manufacturer Narrative

The lens heat shield/holder from the dental light has a three prong locking mechanism which locks the lens heat shield/cover into place.The lens heat shield/cover has to be removed by the end user when cleaning the lens or replacing the halogen bulb during routine operator maintenance.The installation instructions, use and care instructions, and labeling clearly state to ensure the lens heat shield/holder is properly secure by snapping the part back into place.Marus initiated a recall on (b)(6) 2011 to add a tether to the lens heat shield/cover to keep it from falling off the dental light if it is not re-installed properly.The fda closed this recall on 10/26/2012 (please reference fda recall z-2834-2011).Marus notified the distributor of the recall while the recall was open.The distributor responded back to marus and acknowledged the recall but apparently the distributor did not install the tether kit at this one particular dental practice.Marus received the initial complaint notification from an attorney with limited and vague information.Marus was able to identify the end user via an internet search and successfully contacted them on 8/25/16.Marus confirmed the incident and was able to obtain additional information about this event.Marus is shipping a tether kit at no charge to the doctor for installation.

Event Description

A dental professional was performing routine medical treatment to a patient when the lens heat shield/holder fell off the dental light and onto the patients chest causing a red burn.The dental assistant applied a wet paper towel and ice to the red burn area.

• Brand Name: LUXSTAR ORBIT MOUNT LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): MARUS; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 5904768
• MDR Text Key: 54040798
• Report Number: 1017522-2016-00021
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: OL1000
• Device Catalogue Number: OL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2004
• 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