MAUDE Adverse Event Report: MARUS LUXSTAR STANDARD POST-MOUNT LIGHT; DENTAL LIGHT

Model Number UL1000

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

Patient Problem Burn, Thermal (2530)

Event Date 01/13/2017

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 all distributors of the recall while the recall was open.The doctor and his current service provider could not locate the serial number on this particular light.They both informed marus the light was very old and the serial number tag must have somehow been removed.After following back up with the dentist on 2/8/2017, the dental office informed marus the tether was installed on the dental light and it is working properly.

Event Description

A dental professional was treating a patient when the lens heat shield cover fell off a marus dental light hitting the patient on the neck causing a small burn.There were no serious injuries reported.No medical attention was required.

• Brand Name: LUXSTAR STANDARD POST-MOUNT LIGHT
• Type of Device: DENTAL 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: 6312880
• MDR Text Key: 67243485
• Report Number: 1017522-2017-00005
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UL1000
• Device Catalogue Number: UL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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