MAUDE Adverse Event Report: MARUS MARUS LUXSTAR; DENTAL LIGHT

Model Number UL1000

Device Problem Device Maintenance Issue (1379)

Patient Problems Contusion (1787); Laceration(s) (1946)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

An authorized marus distributor service technician visually inspected the marus ul1000 dental light at the doctors office.It was identified that the tether was not attached to the lens heat shield cover.The tether will prevent the lens heat shield cover from falling off the light if it is not properly reinstalled after routine maintance.The lense heat shield cover has to be removed during routine maintenance when replacing the halogen light bulb or cleaning the lens covers.On (b)(6) 2018, the distributor service technician informed marus they installed the tether on the ul1000 dental light the prior week.

Event Description

A dentist was positioning a marus dental light for use when the lense heat shield cover fell off the light and hit the patient on the lip causing a small contusion and laceration.There were no serious injuries reported.

• Brand Name: MARUS LUXSTAR
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 7579523
• MDR Text Key: 110454797
• Report Number: 1017522-2018-00018
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: UL1000
• Device Catalogue Number: UL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• 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: 39 YR