BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S.

    MDR report key: 2214094 · Received July 20, 2011

    Report

    Report Number
    3005174370-2011-00002
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    NOF
    PMA / PMN Number
    K073199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTAL OFFICE REPORTED THAT THREE EVENTS OCCURRED WITHIN A 2-DAY PERIOD USING THE SAME LAVA C.O.S. DEVICE. THEREFORE, THREE REPORTS ARE BEING SUBMITTED AND THIS REPORT IS RELATED TO MANUFACTURER REPORT NUMBER 3005174370-2011-00003 AND 3005174370-2011-00004. AFTER EQUIPMENT INSTALLATION AND INITIAL TRAINING BUT BEFORE 3M COMPLETED ITS OFFICIAL CERTIFICATION TRAINING FOR THE DENTIST, HE USED THE LAVA C.O.S. TO PERFORM A SCAN OF A PT DURING WHICH TIME THE FIRST EVENT OCCURRED. DURING THE SCANNING PROCEDURE, THE DENTIST STATED THAT HE FELT A PALPABLE CURRENT WHEN HOLDING THE TIP OF THE WAND ON HIS PALM. A MILD SHOCK OCCURRED TO THE PT WHEN THE DENTIST TOUCHED THE PTS TEETH WITH HIS FINGER; BUT THE DENTIST DID NOT FEEL THE SHOCK HIMSELF.: OTHER: SERIAL NUMBER (B)(4) REFERS TO THE UNIQUE SERIAL NUMBER OF THE SCANNING WAND COMPONENT OF THE LAVA C.O.S. DEVICE WITH A MANUFACTURE DATE OF 04/2010. ADDITIONAL METHOD: AN ELECTRICAL SAFETY CHECK IN THE DENTAL OFFICE REVEALED THAT THERE WAS A ELECTRICAL POTENTIAL BETWEEN THE NEUTRAL LINE AND THE PROTECTIVE EARTH ON EVERY POWER OUTLET THE LAVA C.O.S. DEVICE WAS CONNECTED TO (RANGING FROM 0.9V TO 18V) AND THE VOLTAGE WAS STABLE. ALSO, AN INITIAL CHECK OF THE ELECTRICAL SAFETY OF THE DEVICE WAS CHECKED IN THE OFFICE-THE LAVA C.O.S. DEVICE MET ITS ELECTRICAL SAFETY SPECIFICATION. SUBSEQUENTLY, THE LAVA C.O.S. DEVICE WAS RETURNED TO 3M ESPE AND WAS VISUALLY INSPECTED AND ELECTRICALLY TESTED. VISUAL INSPECTION OF THE WAND SHOWED A SMALL GAP BETWEEN THE PLASTIC HOUSING AND THE METAL TIP OF THE WAND. HOWEVER, ELECTRICAL TESTING CONFIRMED THE DEVICE MET ALL ELECTRICAL SPECIFICATIONS. 3M ESPE REVIEWED THE EXISTING USER MANUAL; IT INSTRUCTS THE USER TO EXAMINE THE WAND AND THE SYSTEM (CART, SCREEN, ETC.) FOR PHYSICAL DAMAGE BEFORE EACH USE AND TO CONTACT CUSTOMER SUPPORT IF THERE IS VISIBLE DAMAGE. CONCLUSION: AT THIS TIME 3M ESPE CONCLUDES THAT THE LAVA C.O.S. DEVICE ITSELF DID NOT CAUSE THE ELECTRICAL SHOCKS BUT ACTED AS A CONDUCTOR FROM A DEFECTIVE SOCKET. 3M ESPE CONTINUES TO INVESTIGATE THIS EVENT AND WILL PROVIDE SUPPLEMENTAL REPORTS, AS APPROPRIATE.

    Description of Event or Problem · 1

    3M ESPE WAS NOTIFIED ON (B)(6) 2011, THAT ONE PT RECEIVED A MILD ELECTRICAL SHOCK WHEN SCANNED WITH A 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (C.O.S.). THE PT REPORTED PAIN IN THE TEETH FOR 2-3 HOURS FOLLOWING THE SHOCK. THE PT DID NOT SEEK ADDITIONAL MEDICAL ATTENTION AND NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S. ORAL SCANNER NOF 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other