MAUDE Adverse Event Report: MARUS LUZSTAR TRACK-MOUNT LIGHT; DENTAL LIGHT

Model Number TL1000

Device Problem Break (1069)

Patient Problem Contusion (1787)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported that a dentist was using a marus dental light during a routine dental procedure when the dental light fell down towards the ground hitting the pt on the right ear lobe causing a small contusion.There were no serious injuries reported.

Manufacturer Narrative

Upon evaluation by the marus distributor it was identified that the pivot rotational stop screw had broken off due to a suspected excessive external force.This in turn caused damage to the brass pivot retainer which lead to the flex arm pivot to drop out of the suspension tube causing the light to fall down towards the ground.

• Brand Name: LUZSTAR TRACK-MOUNT LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4490703
• MDR Text Key: 5568094
• Report Number: 1017522-2015-00002
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TL1000
• Device Catalogue Number: TL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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: 8 YR