BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART IQ MEASUREMENT CABLE

    MDR report key: 10577271 · Received September 23, 2020

    Report

    Report Number
    8031010-2020-00067
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Report Date
    September 15, 2020
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. RECEIVED - 1X X-SMART IQ HANDPIECE H105900000000 SN: (B)(4). 1X PROPEX IQ PROPEX IQ UNIT BSPPPIQ000002 SN: (B)(4). 1X PROPEX IQ X-SMART IQ MEASUREMENT CABLE B00PPIQ1ACHPA. X-SMART IQ HANDPIECE, SAV VARIOUS ELECTRONIC PROBLEM, CONNECTOR BAD CONTACT. PROPEX IQ X-SMART IQ MEASUREMENT CABLE, SAV VARIOUS CABLE PROBLEM, BAD CONTACT. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PROPEX IQ COMBINED WITH A X-SMART IQ MEASUREMENT CABLE WAS GIVING INCORRECT MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041823 X-SMART IQ MEASUREMENT CABLE LOCATOR, ROOT APEX LQY MAILLEFER INSTRUMENTS HOLDING SARL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1