BEUDAMED
    FDA Adverse Event Summary report: N

    DESONICS ULTRASONIC SCALER

    MDR report key: 29016 · Received December 20, 1995

    Report

    Report Number
    MW4000972
    Date Received
    December 20, 1995
    Report Date
    May 3, 1995
    Manufacturer
    YORK DIV. DENTSPLY INTL, INC.
    Product Code
    ELC
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FROM 12/94 TO 1/95, FACILITY HAS EXPERIENCED NUMEROUS PROBLEMS WITH THE NEW SONIC SCALERS THAT WERE PURCHASED IN LIEU OF ANOTHER MODEL SONIC SCALER. THE TIPS HAVE BROKEN FROM THE HANDPIECES IN PT'S MOUTHS ON TWO SEPARATE OCCASIONS. IT WAS VERY FORTUNATE THAT THE PTS DID NOT SUSTAIN ANY INJURY FROM THESE INCIDENTS. THE DANGER IS REAL CONSIDERING THE SHARPNESS AND THE ROTATION OF THE TIP. THE NARROW AND POINTED TIP COULD EASILY BE ASPIRATED BY THE PT OR LODGED IN THE PT'S SOFT TISSUES. THE CLINICIANS ALSO REPORTED INCIDENTS IN WHICH THE TIPS OF THE SCALERS BROKE OFF WHEN THEY WERE REMOVED FROM THE HANDPIECES TO BE STERILIZED AFTER TREATING PTS. SIX OUT OF 30 SCALERS ALSO FAILED TO VIBRATE AT THE CORRECT RPM AND HAD TO BE RETURNED TO THE MFR FOR REPLACEMENT. FOR A NEW PIECE OF EQUIPMENT, USED AND MAINTAINED IN STRICT ACCORDANCE WITH THE MFR'S GUIDELINES, THIS IS UNSATISFACTORY. THE SCALERS ALSO GENERATE VERY HIGH PITCHED SOUNDS WHICH CAN BE DETRIMENTAL TO THE CLINICIAN'S HEARING. IN ADDITION, SCALERS ARE QUITE INEFFECTIVE IN THE REMOVAL OF CALCULUS, THE MAIN PURPOSE FOR WHICH THEY ARE INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESONICS ULTRASONIC SCALER ULTRASONIC SCALER ELC YORK DIV. DENTSPLY INTL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *