LUXSTAR UNIT MOUNT LIGHT UL1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-16 for LUXSTAR UNIT MOUNT LIGHT UL1000 manufactured by Marus.

Event Text Entries

[48408593] 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 (b)(6) 2012 (please reference fda recall (b)(4). 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 (b)(6) 2016, the dental practice informed marus the tether was now installed on the dental light and is working without any problems.
Patient Sequence No: 1, Text Type: N, H10


[48408594] 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 nose. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017522-2016-00014
MDR Report Key5730276
Date Received2016-06-16
Date of Report2016-05-17
Date of Event2016-05-17
Date Mfgr Received2016-05-17
Device Manufacturer Date2009-05-15
Date Added to Maude2016-06-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. FRANK RAY
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal28273
Manufacturer Phone7045877227
Manufacturer G1MARUS
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal Code28273
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLUXSTAR UNIT MOUNT LIGHT
Generic NameDENTAL OPERATING LIGHT
Product CodeEAZ
Date Received2016-06-16
Model NumberUL1000
Catalog NumberUL1000
OperatorDENTAL HYGIENIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMARUS
Manufacturer Address11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-16

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