BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTTORQUE LUX S619 L

    MDR report key: 19179922 · Received April 25, 2024

    Report

    Report Number
    3003637274-2024-00014
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 25, 2024
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K093341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE VISUAL AND FUNCTIONAL INSPECTION PRIOR TO THE REPAIR IT WAS ALREADY NOTICEABLE THAT THE RETENTION FORCE OF THE CHUCK SYSTEM WAS TOO LOW AND HENCE THE BURS HAVE NOT BEEN HELD CORRECTLY. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE IT: 2.2 TECHNICAL CONDITION: A DAMAGED DEVICE OR COMPONENTS COULD INJURE PATIENTS, USERS AND THIRD PARTIES. -> ONLY OPERATE DEVICES OR COMPONENTS IF THEY ARE UNDAMAGED ON THE OUTSIDE. -> CHECK THAT THE DEVICE IS WORKING PROPERLY AND IS IN SATISFACTORY CONDITION BEFORE EACH USE -> HAVE PARTS WITH SITES OF BREAKAGE OR SURFACE CHANGES CHECKED BY THE SERVICE. -> IF THE FOLLOWING DEFECTS OCCUR, STOP WORKING AND HAVE THE SERVICE PERSONNEL CARRY OUT REPAIR WORK: * MALFUNCTIONS * DAMAGE * IRREGULAR RUNNING NOISE * EXCESSIVE VIBRATION * OVERHEATING * TOOL IS NOT SEATED FIRMLY IN THE HANDPIECE -> FOLLOWING EXPIRY OF THE WARRANTY, HAVE THE TOOL HOLDING SYSTEM CHECKED ONCE A YEAR. -> KAVO RECOMMENDS SPECIFYING IN-HOUSE SERVICE INTERVALS WHERE THE MEDICAL DEVICE IS BROUGHT TO A PROFESSIONAL SHOP FOR CLEANING, SERVICING AND A FUNCTION CHECK. DEFINE THE SERVICE INTERVAL DEPENDING ON THE FREQUENCY OF USE. CAUTION: DEFECTIVE CLAMPING SYSTEM. RISK OF INJURY, DENTAL BUR MAY FALL OUT DURING TREATMENT. ->PULL ON THE DENTAL BUR TO CHECK IF THE CLAMPING SYSTEM WORKS PROPERLY AND IF THE DENTAL BUR IS FIRMLY CLAMPED.

    Description of Event or Problem · 0

    DURING A CROWN PREPARATION THE BUR FREED ITSELF FROM THE CHUCK OF THE HANDPIECE AND FELL TO THE BACK OF THE PATIENT'S THROAT WHO SWALLOWED IT. PATIENT WAS SENT TO A&E TO GET X-RAYED AND BUR WAS LOCATED IN ABDOMEN. FURTHER X-RAYS ARE MADE TO ASCERTAIN THAT BUR MOVES AND FINALLY HAS PASSED ON NATURAL WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468120 SMARTTORQUE LUX S619 L DENTAL HANDPIECE EFB KAVO DENTAL GMBH S619 L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown