BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART IQ BASIC STARTER KIT

    MDR report key: 15500899 · Received September 28, 2022

    Report

    Report Number
    8031010-2022-00645
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EBW
    PMA / PMN Number
    K161213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO INJURY THAT OCCURRED FOR THIS EVENT. THIS FOLLOW UP REPORT IS FOR THIS ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    WHILE THERE IS NO INDICATION THAT SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. INVESTIGATION SUMMARY: RECEIVED = 1X X-SMART IQ CONTRA-ANGLE A105100000000 SN: (B)(4). 1X X-SMART IQ HANDPIECE H105900000000 SN: (B)(4). 1X X-SMART IQ UNIVERSAL CHARGER A105300000000 1X PROPEX IQ X-SMART IQ MEASUREMENT CABLE B00PPIQ1ACHPA 1X PROPEX IQ PROPEX IQ CHARGER B00PPIQ1ACCHG 1X PROPEX IQ PROPEX IQ FILE CLIP X2 B00PPIQ2ACFCL 1X PROPEX IQ PROPEX IQ UNIT BSPPPIQ000002 SN: (B)(4). X-SMART IQ CONTRA-ANGLE. SAV VARIOUS MECHANICAL PROBLEM. NOISY, NOT FLUID ROTATION. X-SMART IQ HANDPIECE. SAV OTHER. CONNECTOR BROKEN. PROPEX IQ PROPEX IQ UNIT. SAV DEFECTIVE BATTERY. BATTERY DISCHARGING TOO FAST. PROPEX IQ X-SMART IQ MEASUREMENT CABLE. SAV VARIOUS CABLE PROBLEM. BAD CONTACT. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT X-SMART IQ BASIC STARTER KIT WAS NOT HAVING A FLUID ROTATION AND WHILE IN USE WITH PROPEX IQ APEX LOCATOR THE DEVICE WAS GIVING INCORRECT MEASUREMENTS. OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302219 X-SMART IQ BASIC STARTER KIT CONTROLLER, FOOT, HANDPIECE AND CORD EBW MAILLEFER INSTRUMENTS HOLDING SARL 1046, 25572,00662

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown