MAUDE Adverse Event Report: MARUS LUXSTAR CEILING MOUNT LIGHT; DENTAL OPERATING LIGHT

Model Number CL1000

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

A dental professional was performing routine medical treatment to a patient when the lens heat shield/holder fell off the dental light and onto the patient's neck causing a small red mark.No medical attention was required.

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.Dental equipment llc (dba 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).(b)(4) notified the distributor of the recall while the recall was open.The distributor responded back to (b)(4) 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) 2014, the dentist informed (b)(4) the tether was installed on the dental light the prior week.

• Brand Name: LUXSTAR CEILING MOUNT LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray, manager ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 3870124
• MDR Text Key: 4506134
• Report Number: 1017522-2014-00006
• 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
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL1000
• Device Catalogue Number: CL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• 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: 44 YR