BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M ESPE LAVA CHAIRSIDE ORAL SCANNER (COS)

    MDR report key: 2961835 · Received February 8, 2013

    Report

    Report Number
    3005174370-2013-00002
    Event Type
    Other
    Date Received
    February 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    NOF
    PMA / PMN Number
    K073199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, A REPRESENTATIVE OF 3M VISITED THE INITIAL VISIT, THE DEVICE CHECKED OUT AS PERFORMING AS INTENDED AND IT WAS DETERMINED THAT ADDITIONAL TEST EQUIPMENT WAS NEEDED IN ORDER TO FULLY UNDERSTAND THE CAUSE OF THIS COMPLAINT. ON (B)(4) 2013, IT WAS DETERMINED THAT THE GROUND IN THE WALL OUTLET COMMONLY USED FOR POWERING THE SCANNER HAD NO CONNECTION BETWEEN THE GROUND PIN AND THE COPPER WATER PIPE IN OFFICE (COPPER WATER PIPE RUNNING TO GROUND). IT WAS ALSO FOUND THAT THE GROUND CONTACT OF THAT OUTLET WAS RECESSED TO A POINT WHERE IT COULD NOT MAKE CONTACT WITH A GROUND PIN ON THE POWER CORD. THE DENTIST WAS ADVISED OF THESE OBSERVATIONS AND WAS GOING TO CALL IN AN ELECTRICIAN TO CHECK OUT THE ELECTRICAL WIRING IN THE DENTAL OFFICE AND ENSURE THAT THE OUTLETS USED FOR THE SCANNER ARE PROPERLY GROUNDED. 3M ESPE NOTES THAT THE LAVA C.O.S. USER MANUAL INFORMS THE USER THAT THEY MUST USE A PROPERLY GROUNDED OUTLET.

    Description of Event or Problem · 1

    3M ESPE WAS INFORMED THAT OCCASIONALLY WHEN SCANNING PATIENTS WITH THE 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (COS), THE PATIENT REPORTS THAT THE WAND GAVE THEM A SHOCK. NO PATIENT SOUGHT MEDICAL ATTENTION AND NO SERIOUS INJURY OCCURRED AS A RESULT OF THE SHOCK. THIS EVENT, REPORTED TO 3M ESPE ON (B)(6) 2012, WAS INVESTIGATED BY A TRAINED SERVICE TECHNICIAN IN (B)(6) 2012 AND THE LAVA COS UNIT WAS FOUND TO BE PERFORMED AS INTENDED; IT WAS DETERMINED THAT FURTHER INVESTIGATION TO UNDERSTAND THE REPORTED ISSUE AND MAKE AN INFORMED REPORTING DECISION WAS NECESSARY. UPON THIS INVESTIGATION, IT WAS DETERMINED THAT THE OUTLET COMMONLY USED FOR THE SCANNER WAS NOT PROPERLY GROUNDED. WITHOUT PROPER GROUND, IT IS POSSIBLE FOR PATIENTS TO RECEIVE AN ELECTRICAL SHOCK (LEAKAGE CURRENT TO PATIENT INSTEAD TO GROUND) FROM USE OF THIS DEVICE. THIS LEAKAGE CURRENT IS LIMITED BY THE USE OF A MEDICAL GRADE POWER SUPPLY. UNDER MULTIPLE FAULT CONDITIONS (INCLUDING LOSS OF GROUND) THE PATIENT CURRENT COULD POTENTIALLY EXCEED THE LIMITS OF IEC 60601-1, WHICH LED TO THIS REPORT. SINCE THE SCANNER PERFORMED AS INTENDED, BUT INADEQUATE GROUND WIRING IN THE OFFICE RESULTED IN PATIENTS RECEIVING AN ELECTRICAL SHOCK, THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54922 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (COS) OPTICAL IMPRESSION SYSTEM NOF 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other