BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 8542065 · Received April 23, 2019

    Report

    Report Number
    1219602-2019-00459
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 6, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010555694
    PMA / PMN Number
    E527289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DYONICS DISPOSABLE 3.5MM INCISOR PLUS ELITE BLADE RETURNED. THE COMPLAINT STATED: ¿THE BLADE MADE A NOISE AND RELEASED SMOKE.¿ THE BLADE WAS FOUND SEIZED. ONCE THE INNER AND OUTER WERE FREED, WEAR BANDS AND SKIVING WAS VISIBLE ON THE INNER BLADE AND INSIDE THE OUTER BLADE CUP. ACCUMULATED SHAVINGS WERE STILL ATTACHED WHICH BOUND THE BLADE. DRAG WAS FELT WITH ROTATION OF THE INNER AND OUTER BLADES. THESE SYMPTOMS WERE CAUSED BY DISTAL PRESSURE APPLIED. AS A RESULT, BINDING, SHAVINGS AND SEIZING OCCURRED. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE MADE A NOISE AND RELEASED SMOKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335556 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 03596010555694

    Patients

    Seq Age Sex Outcome Treatment
    1