BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACK MOUNTED DENTAL LIGHT

    MDR report key: 11854243 · Received May 20, 2021

    Report

    Report Number
    1017522-2021-00001
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    October 21, 2020
    Report Date
    June 23, 2021
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DENTIST RETURNED THE DENTAL LIGHT TO KAVO DENTAL TECHNOLOGIES, LLC (DBA PELTON & CRANE) ON (B)(6) 2021 FOR EVALUATION. AS A RESULT OF THE EVALUATION IT WAS DETERMINED THAT THE ROLL PIN AND 2 OF 4 SET SCREWS WERE NOT PROPERLY INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE ROLL PINS AND SET SCREWS WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE TROLLEY AND/OR POST AFTER INSTALLATION. THE PELTON & CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE ROLL PINS AND SET SCREWS DURING INSTALLATION OF THE TRACK LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LISTS WARNINGS TO ENSURE THE ROLL PINS AND SET SCREWS ARE INSTALLED. (B)(6) (PELTON & CRANE QUALITY SPECIALIST) CONTACTED THE DR'S OFFICE ON (B)(6) 2021 AND SPOKE WITH DANIELLE WITH THE FRONT OFFICE, AND INFORMED DANIELLE THAT THE CAUSE OF FAILURE WAS DUE TO IMPROPER INSTALLATION BY HER DEALER. THIS CONCLUDES THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TO DATE. ATTEMPTS ARE BEING MADE TO HAVE THE LIGHT RETURNED FOR EVALUATION AND IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED, AND A FOLLOW UP REPORT SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF THE EVENT, A PATIENT WAS IN THE ROOM IN THE DENTAL CHAIR AND THE DENTAL ASSISTANT WAS STANDING BEHIND THE PATIENT. THE LIGHT WAS SEMI FOLDED AND TO THE SIDE OF THE PATIENT, THE LIGHT FELL STRIKING THE DENTAL ASSISTANT ON THE RIGHT SHOULDER AND RIGHT HAND. THE LIGHT DID NOT HIT THE PATIENT AND THE LIGHT WAS NOT IN USE AT THE TIME OF THE INCIDENT. THE LIGHT BROKE/CAME APART AT THE ELBOW/BEND IN THE MECHANICAL ARM. ONCE THE LIGHT FELL AND HIT THE FLOOR, THE HEAD BROKE AT THE HANDLE/YOKE. THE DENTAL ASSISTANT WENT TO THE LOCAL URGENT CARE FOR TREATMENT AND HER ARM WAS PUT IN A SPLINT. THE DENTAL ASSISTANT CHOSE NOT TO RETURN TO WORK AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752368 TRACK MOUNTED DENTAL LIGHT DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC HL3T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other