MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC LUXSTAR STANDARD POST-MOUNT LIGHT; DENTAL LIGHT

Model Number UL1000

Device Problem Device Handling Problem (3265)

Patient Problem Burning Sensation (2146)

Event Date 10/28/2020

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.The light was manufactured in october 2001 and is over 19 years old and past its expected life.This concludes the investigation.

Event Description

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

• Brand Name: LUXSTAR STANDARD POST-MOUNT LIGHT
• 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: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 10944443
• MDR Text Key: 219529704
• Report Number: 1017522-2020-00014
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• 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: 11/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2001
• 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