BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE WITH DOT SCANNER

    MDR report key: 19873415 · Received July 31, 2024

    Report

    Report Number
    1222993-2024-00041
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 31, 2024
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INJURY NEAR THEIR EYES DUE TO DEVICE'S ARM FALLING ONTO THEM DURING TREATMENT. PATIENT RECEIVED STITCHES AS MEDICAL INTERVENTION. CYNOSURE CLINICAL INVESTIGATED THE EVENT AND DETERMINED IT WAS INCONCLUSIVE. TREATMENT SETTINGS WERE REQUESTED, BUT NONE WAS PROVIDED. FIELD SITE ENGINEER (FSE) ARRIVED AT THE SITE AND INVESTIGATED THE DEVICE. FSE RETIGHTENED THE TOP SCREW, FILLED THE CONNECTING ROD HOLE WITH GLUE, AND TIGHTENED THE CABLE TIE. LOOSE SCREWS HAD CAUSED THE ARM TO FALL, BUT IT IS UNCLEAR IF IT WAS RELATED TO DEVICE MALFUNCTION OR USER ERROR. SINCE THE PATIENT RECEIVED MEDICAL INTERVENTION, THIS EVENT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863074 DEKA SMARTXIDE WITH DOT SCANNER SMARTXIDE DOT GEX EL. EN. ELECTRONIC ENGINEERING S.P.A M079S1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention