BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GX 770 INTRAORAL X-RAY SYSTEM

    MDR report key: 1843099 · Received September 23, 2010

    Report

    Report Number
    3004115000-2010-00017
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT OR USER INJURY WITH THIS EVENT. A DEALER SERVICE TECHNICIAN PERFORMED AN ON-SITE INSPECTION OF THE X-RAY UNIT. THE TUBEHEAD HAD DISCONNECTED FROM THE YOKE, SEVERING THE WIRES WHEN IT FELL. THE DEALER SERVICE TECHNICIAN NOTED THAT THE TUBEHEAD ON THIS X-RAY UNIT HAD BEEN REPLACED BEFORE. DUE TO THE DISCONNECTION OF THE HARDWARE, A CONCLUSION ON THE INCIDENT COULD NOT BE DETERMINED AT THIS TIME. THE MANUFACTURER HAS REQUESTED RETURN OF THE COMPONENTS FOR FURTHER EVALUATION. ON THE GX770 X-RAY UNITS, THE YOKE CONNECTS TO THE SIDESHAFT OF THE TUBEHEAD. THE SIDE SHAFT OF THE TUBEHEAD IS SECURED TO THE YOKE WITH A KEYED WASHER PLACED ONTO A KEYWAY ON THE SHAFT, THEN A FLAT WASHER, TWO WAVE WASHERS AND ANOTHER FLAT WASHER ARE PLACED ONTO THE SHAFT. A LOCKING RING IS TIGHTENED ONTO THE TUBEHEAD SHAFT. A SET SCREW IN THE YOKE IS THEN TIGHTENED TO SECURE THE LOCKING RING IN PLACE. DURING REGULAR USE OF THE X-RAY UNIT, THE LOCKING RING MAY REQUIRE ADJUSTMENTS TO MAINTAIN PROPER ROTATION OF THE TUBEHEAD. THE PRODUCT LABELING SUPPLIED WITH THE X-RAY UNIT DESCRIBES THE MECHANICAL ADJUSTMENTS THAT MAY BE NEEDED DURING INSTALLATION AND MAINTENANCE. THE DENTAL OFFICE DECIDED TO NOT TO REPAIR THE X-RAY UNIT.

    Additional Manufacturer Narrative · 1

    THE TUBEHEAD WAS RECEIVED BY THE MANUFACTURER FOR INSPECTION. THE PIECES OF HARDWARE, TWO FLAT WASHERS, TWO WAVE WASHERS, AND LOCKING RING WITH A SET SCREW WERE ALSO RETURNED. THE INSPECTION DID NOT FIND ANY DAMAGE TO THE HARDWARE OR SIDE SHAFT OF THE TUBEHEAD. THE WIRES COMING FROM THE SIDE SHAFT WERE BROKEN OFF AS REPORTED IN THE ORIGINAL INCIDENT DESCRIPTION. IN CONCLUSION IT WAS DETERMINED THAT IMPROPER INSTALLATION OF THE TUBEHEAD DURING SERVICING OR MAINTENANCE CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    THE TUBEHEAD FELL OFF OF THE INTRAORAL X-RAY UNIT DURING USE. THE DENTAL ASSISTANT WAS POSITIONING A PATIENT FOR A DENTAL X-RAY. THE TUBEHEAD GRAZED THE PATIENT'S SHOULDER WHEN IT FELL. THE DENTAL ASSISTANT CAUGHT THE TUBEHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GX 770 INTRAORAL X-RAY SYSTEM DENTAL X-RAY EQUIPMENT EHD GENDEX DENTAL SYSTEMS 46-404600G6

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR