MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC MARUS LUXSTAR; DENTAL LIGHT

Model Number UL1000

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problems Contusion (1787); Swelling (2091)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

An authorized distributor service technician visually inspected the marus ul1000 dental light at the doctors office and determined the lense heat shield cover had not been properly re-attached to the marus ul1000 dental light during routine maintenance by the end user.The lense heat shield cover has to be removed during routine maintenance when replacing the halogen light bulb or cleaning the lens covers.The use and care manual identifies how to properly re-install the lense heat shield cover after performing routine maintenance as well as list warnings to insure the lense heat shield cover is properly installed after servicing.The distributor service technician informed the manufacturer they properly installed the lense heat shield cover on the ul 1000 dental light.This concludes the investigation.

Event Description

It was reported a dentist was positioning a marus ul1000 dental light for use when the lense heat shield cover fell off the light and hit the patient on the forehead causing a bruise and swelling.The dentist gave the patient an ice pack for the swelling.There were no serious injuries reported.

• Brand Name: MARUS LUXSTAR
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 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: 8081206
• MDR Text Key: 128081957
• Report Number: 1017522-2018-00030
• 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: Dentist
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1999
• 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: 58 YR