BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX II EUR

    MDR report key: 15065015 · Received July 20, 2022

    Report

    Report Number
    8031010-2022-00608
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Report Date
    September 1, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INSPECTION FOUND: RECEIVED = 1X PROPEX II MEASURING WIRE A102900000500. 1X PROPEX II UNIT SN: (B)(6). PROPEX II MEASURING WIRE. VARIOUS CABLE PROBLEM. THE CABLE IS DAMAGED. PROPEX II KIT PCB TFT CHASSIS. DEFECT. REPLACED 1X P2 UNIT 1141252. 1X P2 MEASURING WIRE A102900000500.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PROPEX II EUR WAS GIVING INCORRECT MEASUREMENTS. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390069 PROPEX II EUR LOCATOR, ROOT APEX LQY MAILLEFER INSTRUMENTS HOLDING SARL PII-1141252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown