BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITERO LUMINA SCANNING UNIT

    MDR report key: 22327742 · Received June 25, 2025

    Report

    Report Number
    3009646999-2025-00430
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ALIGN TECHNOLOGY, LTD.
    Product Code
    NOF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT USER MANUAL CONTAINS THE FOLLOWING: "SCANNER PRECAUTIONS - AVOID TWISTING, KNOTTING, PULLING, AND STEPPING ON THE WAND CABLE AND THE POWER CABLE", "WARNING - DO NOT CONNECT THE SCANNER TO A MAIN SUPPLY WITHOUT PROTECTIVE GROUNDING, IN ORDER TO AVOID THE RISK OF ELECTRICAL SHOCK.". THIS EVENT IS BEING FILED AS AN MDR AS THE USER EXPERIENCED A MINOR INJURY ON HAND, REQUIRING MEDICAL CARE, AND THE ALIGN TECHNOLOGY, LTD MEDICAL DEVICE WAS BEING USED. INVESTIGATION OF THIS EVENT IS CURRENTLY ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE DEVICE INVOLVED IN THE REPORTED EVENT HAS BEEN COMPLETED. FINDINGS INDICATE THAT THE INCIDENT IS ASSOCIATED WITH A PREVIOUSLY IDENTIFIED ISSUE, WHICH HAS ALREADY BEEN ADDRESSED THROUGH DESIGN MODIFICATIONS IN THE ACCESSORY COMPONENTS. THE COMPONENT IMPLICATED IN THIS EVENT BELONGS TO AN EARLIER DESIGN ITERATION. THE INVESTIGATION ALSO REVEALED A MISCOMMUNICATION BETWEEN THE USER AND THE SUPPORT AGENT, RESULTING IN THE DISPATCH OF AN INCORRECT COMPONENT. FURTHERMORE, BASED ON THE USER INTERVIEW, IT WAS DETERMINED THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS OUTLINED IN THE USER MANUAL REGARDING THE CORRECT SEQUENCE FOR CONNECTING THE COMPONENTS. THE DEVICE INVOLVED IN THE EVENTS IS A LUMINA DEVICE THAT HAS BEEN UPGRADED FROM A 5D DEVICE. THE 5D DEVICE HAS BEEN ACTIVE SINCE MAY-2021, THUS THE INVOLVED COMPETENT IS ABOUT 4 YEARS OLD. THIS DEVIATION FROM THE RECOMMENDED PROCEDURE CONTRIBUTED TO SUBSEQUENT HARM TO THE USER. SECTION H6 CODES UPDATED TO REFLECT THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AT THE MOMENT OF THE EVENT WHEN THE CHARGER WAS PLUGGED INTO THE POWER OUTLET IT BLEW UP, CAUSING A SKIN BURN IN THE HAND AND RECEIVED AN ELECTRIC SHOCK. THE USER REQUIRED A MEDICAL CHECK, AND WAS REVIEWED BY A CARDIOLOGIST, SURGEON AND OCCUPATIONAL MEDICINE DOCTOR AND IT IS UNKNOWN IF MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130949 ITERO LUMINA SCANNING UNIT SYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) NOF ALIGN TECHNOLOGY, LTD. 222100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other