BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR STANDARD UNIT MOUNT LIGHT

    MDR report key: 3167762 · Received June 11, 2013

    Report

    Report Number
    1017522-2013-00009
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MARUS
    Product Code
    EAZ
    Removal / Correction Number
    Z-2834-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. DENTAL EQUIPMENT LLC (DBA MARUS) INITIATED A RECALL ON 06/10/2011 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 REF FDA RECALL Z-2834-2011). MARUS NOTIFIED THE DISTRIBUTOR OF THE RECALL NUMEROUS TIMES WHILE THE RECALL WAS OPEN. THE DISTRIBUTOR RESPONDED BACK TO MARUS 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 DISTRIBUTOR, THE DISTRIBUTOR WENT TO THE DENTAL OFFICE AND INSTALLED THE TETHER KIT ON (B)(4) 2013.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PT WHEN THE LENS HEAT SHIELD/HOLDER FORM HIS DENTAL LIGHT CAME OFF THE LIGHT AND FELL ONTO THE ARMREST OF THE DENTAL CHAIR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264644 LUXSTAR STANDARD UNIT MOUNT LIGHT DENTAL OPERATING LIGHT EAZ MARUS UL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR