BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANAO

    MDR report key: 5022382 · Received August 19, 2015

    Report

    Report Number
    2529090-2015-21020
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    February 1, 2015
    Report Date
    August 7, 2015
    Manufacturer
    SCICAN GMBH
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE ON A PATIENT USING THE SANAO 200L HANDPIECE, THE PATIENTS LIP WAS BURNED. EVENT OCCURRED IN (B)(6) 2015, REPORTED TO SCICAN (B)(6) 2015. THE DENTAL PRACTICE CONTINUED TO USE THE HANDPIECE OVER THE NEXT SEVERAL MONTHS, NOTING IT CONTINUED TO SEEM HOT. STATED A FEW OTHER PATIENTS MAY HAVE RECEIVED MINOR BURNS, BUT HAD NO ADDITIONAL DETAILS OR DATES. COMPLAINED DURING USE IT WOULD MAKE A LOUD NOISE NEAR THE END OF THE PROCEDURE. A PHONE CALL WAS FOR A RETURN AUTHORIZATION NUMBER WAS MADE FROM THE DEALER, PATTERSON DENTAL, REQUESTING A REPAIR DUE TO HEATED BACK CAP. THE FOLLOWING SAFETY INFORMATION HAS BEEN PROVIDED IN THE IFU WITH REGARD TO THE USE OF ELECTRIC MICRO-MOTORS: "RISKS WHEN USING HANDPIECES WITH ELECTRICAL MICRO-MOTORS. ELECTRICAL MICRO-MOTORS GENERATE SIGNIFICANTLY MORE ENERGY THAN CONVENTIONAL AIR TURBINES AND AIR MOTORS. DUE TO THE HIGH TORQUES AND SPEEDS, POORLY SERVICED, DAMAGED OR MISUSED HANDPIECES MAY LEAD TO OVERHEATING WHICH COULD INFLICT SEVERE BURNS ON THE PATIENT. PLEASE OBSERVE THE FOLLOWING. CAREFULLY FOLLOW THE MAINTENANCE INSTRUCTIONS. INSPECT THE HANDPIECE BEFORE EACH USE. ESPECIALLY PAY ATTENTION TO UNUSUAL OVERHEATING, CONSPICUOUS NOISES AND VIBRATIONS. IF A HANDPIECE IS FOUND TO BE FAULTY, ITS USE MUST BE DISCONTINUED IMMEDIATELY. NEVER LIFT CHEEKS OR TONGUES WITH THE HANDPIECE." MFR # 3006028656-2015-01057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548840 SANAO HANDPIECE, ATTACHMENT, DENTAL EGS SCICAN GMBH S20100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention