BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT FANTASTIC

    MDR report key: 8088738 · Received November 20, 2018

    Report

    Report Number
    1017522-2018-00031
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 20, 2018
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE DISTRIBUTOR SERVICE TECHNICIAN IT WAS DETERMINED THE ROLL PINS WERE NOT INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE ROLL PINS WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE CEILING MOUNTED TRIPOD ASSEMBLY AFTER INSTALLATION. THE PELTON & CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE ROLL PINS DURING INSTALLATION OF THE CEILING MOUNTED DENTAL LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LISTS WARNINGS TO ENSURE THE ROLL PINS ARE INSTALLED. THE PELTON & CRANE CEILING MOUNTED DENTAL LIGHT IS OVER 24 YEARS OLD AND PAST THE LIFE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO KAVO DENTAL TECHNOLOGIES, LLC THAT A PELTON & CRANE LFCII DENTAL LIGHT FELL DOWM FROM THE CEILING AND WAS DEFECTED AWAY BY THE DR. DURING ROUTINE PATIENT DENTAL TREATMENT CAUSING A SMALL BRUISE TO THE DOCTOR'S ARM. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928909 LIGHT FANTASTIC DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC HBC

    Patients

    Seq Age Sex Outcome Treatment
    1