BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GX-770

    MDR report key: 3820223 · Received May 1, 2014

    Report

    Report Number
    2530069-2014-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED GX-770 WAS COMPLETED ON (B)(4) 2014. THE MODEL WAS DISCONTINUED IN MARCH 2010, AND THIS DEVICE HAS BEEN IN USE IN THE FIELD FOR MORE THAN 11 YEARS. THE INSPECTION OF THE DEVICE SHOWED THAT ALTHOUGH THE TUBE HEAD BROKE APART FROM THE ARTICULATING ARM AND THE WIRES WERE BROKEN AS A RESULT, THE UNIT WAS MECHANICALLY FUNCTIONAL. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED AS ALL PARTS RECEIVED WERE IN GOOD MECHANICAL CONDITION. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE TUBEHEAD OF THE DEVICE CAME OFF AS THE HYGIENIST WAS POSITIONING THE DEVICE FOR X-RAY. THE HYGIENIST CAUGHT THE TUBEHEAD, IT DID NOT HIT THE PT. THERE WAS NO INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262163 GX-770 EXTRAORAL SOURCE X-RAY SYSTEM EHD GENDEX DENTAL SYSTEMS GX-770

    Patients

    Seq Age Sex Outcome Treatment
    1