BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124

    MDR report key: 16477249 · Received March 3, 2023

    Report

    Report Number
    2424472-2023-00009
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Report Date
    March 3, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K970123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. INVESTIGATION RESULTS: EDH DSP/IF/IC/SCAN BOARD DAMAGED INTERFACE BOARD WAS BURNT AND WAS NOT ABLE TO CONNECT THE G123 PUMP. THE COVER ITSELF ON THE G124 UNIT WHERE THE HANDPIECE IS SUPPOSED TO BE CRADLE IS BURNT. THE STERI-MATE WAS BURNT WHEN IT WAS LAYING IN THE CRADLE OF THE G124 UNIT. DEBRIS WAS BUILT UP IN THE WATER FILTER. ON THE G123 PUMP THE INTERFACE PCB ASSEMBLY WAS BURNT AND DAMAGED ALSO LEADING TO A BURNT PUMP INTERFACE. THE GROMMET BUMPER WAS BURNT AND REPLACED WITH A NEW ONE. ALL TESTING ON THE G124 UNIT AND THE G123 PUMP HAS BEEN CALIBRATED AND TESTED TO MANUFACTURE SPECS. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT G124 CAVITRON SELECT SPS SENT IN FOR REPAIR HAS EVIDENCE OF OVERHEATING THAT WAS FOUND DURING THE REPAIR. WATER WAS TURNED OFF DURING USE. INVESTIGATION FOUND DEBRIS BUILT UP IN WATER FILTER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934245 CAVITRON SELECT SPS G124 SCALER, ULTRASONIC ELC DENTSPLY LLC G124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown