BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON, 115V G136

    MDR report key: 15390668 · Received September 9, 2022

    Report

    Report Number
    2424472-2022-00036
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Report Date
    September 9, 2022
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE LACK OF WATER FLOW HAS CAUSED AN OVERHEATING INSERT. 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 FOUND SAK EMH FOUND HP CABLE STERIMATE CONNECTION BURNT/CORRODED FROM BAD CONNECTION TO STERI-MATE WHICH ALSO HAD A RECEEDED PIN, REPLACED BOTH WITH NEW, VERIFIED TUNING/CALIBRATION AND TESTED ALL FUNCTIONS TESTED QA-MO.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT G136 CAVITRON PLUS HANDPIECE CABLE REPORTEDLY NOT WORKING. INVESTIGATION RESULTS INDICATED THAT THE STERIMATE CONNECTION WAS BURNT/CORRODED, THEREFORE UPGRADED TO SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255665 CAVITRON PLUS TAP-ON, 115V G136 SCALER, ULTRASONIC ELC DENTSPLY LLC G136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown