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

Model Number UL1000

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

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 june 10, 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.After following back up with the dentist on 05/16/2016, the dental practice informed marus the tether was installed on the dental light and is working without any problems.

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 hit the patient on the forehead.There were no injuries reported.

• Brand Name: LUXSTAR UNIT 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: 5659497
• MDR Text Key: 46014005
• Report Number: 1017522-2016-00011
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: UL1000
• Device Catalogue Number: UL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2007
• 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
• Patient Age: 67 YR