BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAVO DIAGNODENT 2095

    MDR report key: 6157469 · Received December 9, 2016

    Report

    Report Number
    3003637274-2016-00074
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 16, 2015
    Report Date
    November 30, 2016
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    NBL
    PMA / PMN Number
    K983658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR THE MANUFACTURER FOR ANALYSIS, BUT A REPRESENTATIVE OF THE LOCAL DEALER VISITED THE CUSTOMER TO CHECK THE ROOT CAUSE. IT TURNED OUT QUICKLY THAT THE SNAP-ON MOUNTING OF THE LIGHT PROBE WAS WORN OUT. IT WAS VERIFIED BY COMPARING THE RETENTION FORCE BETWEEN A NEW LIGHT PROBE (WHICH WAS GOOD) AND THE USED ONE. IT TURNED OUT THAT THE CUSTOMER DID NOT FOLLOW THE STERILIZATION PROCESS AS DESCRIBED IN THE INSTRUCTION FOR USE AND ALSO NOT THE INSTRUCTION HOW TO PREPARE THE PRODUCT FOR USE. HENCE CUSTOMER GOT NOT AWARE THAT THE LIGHT PROBE WAS NOT CORRECTLY IN PLACE. TO AVOID SUCH INCIDENTS THE INSTRUCTION FOR USE CONTAINS ALREADY THE NECESSARY INSTRUCTIONS HOW TO MAINTAIN AND USE THE PRODUCT: OPERATION / HANDLING: SELECT LIGHT PROBE A OR B AND PLACE ON HANDPIECE. MAKE SURE THE PROBE IS PROPERLY SEATED. SETUP METHODS ACCORDING TO DIN EN ISO 17664. RESTRICTION ON REUSE: THE PROBES CAN BE STERILISED MORE THAN 500 TIMES WHEN HANDLED PROPERLY. THE PROBES ARE SUBJECT TO WEAR. STERILISATION: ONLY THE GRIP SLEEVES AND PROBES CAN BE STERILISED UP TO 138°C. THE PROBES CAN BE STERILISED IN THE PROBE HOLDER IN THE STERIBOX.. INSERT THE PROBES IN THE PROBE HOLDER IN THE STERIBOX IN THE RIGHT PROBE STORAGE SPACE. PRODUCT NOT SUPPLIED BY OWNER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DENTAL MEDICAL EXAMINATION THE LIGHT PROBE DETACHED FROM THE GRIP SLEEVE, FELL INTO PATIENTS MOUTH AND WAS SWALLOWED BY PATIENT ((B)(6) INFANT). TWO DAYS LATER THE PROBE WAS DEFECATED ON THE NATURAL WAY WITHOUT CAUSING ANY TROUBLE. NO MEDICAL CARE WAS NECESSARY. THE INCIDENT OCCURED MORE THAN ONE YEAR AGO AND FURTHER DETAILS ARE NOT AVAILABLE. HENCE THE 'DATE OF EVENT' IS BEST ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814968 KAVO DIAGNODENT 2095 CARIES DETECTOR NBL KAVO DENTAL GMBH 2095

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR