BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESRCM 40 .04 25MM

    MDR report key: 21238942 · Received January 27, 2025

    Report

    Report Number
    3006610063-2025-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 3, 2024
    Report Date
    January 9, 2025
    Manufacturer
    FKG DENTAIRE SARL
    Product Code
    EKS
    UDI-DI
    00887919875680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BROKEN DEVICE WAS DISCARDED BY THE USER AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. MANUFACTURING RECORDS HAVE BEEN REVIEWED AND DO NOT SHOW ANY ABNORMALITY. TO DATE, THE INFORMATION THAT HAVE BEEN COLLECTED AND THE OUTCOME OF THE INVESTIGATIONS OF THIS CASE HAVE NOT PERMITTED TO IDENTIFY THE ROOT CAUSE OF THIS BREAKAGE. SINCE THIS ENDODONTIC INSTRUMENT BREAKAGE RESULTS IN LEFT DEBRIS IN THE ROOT CANAL, IT HAS THE POTENTIAL TO NECESSITATE MEDICAL OR SURGICAL INTERVENTION. THIS MALFUNCTION IS THEREFORE REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 0

    WHILE PERFORMING A ROOT CANAL TREATMENT, THE ENDODONTIC FILE (ESRCM 40 .04 25MM) BROKE IN THE PATIENT'S MOUTH. THE BROKEN PIECE WAS LEFT IN THE CANAL AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781532 ESRCM 40 .04 25MM ENDODONTIC FILE EKS FKG DENTAIRE SARL ESRCM 40 .04 25MM LV23 00887919875680

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male