BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE STRAIGHT INCISOR

    MDR report key: 2073224 · Received April 29, 2011

    Report

    Report Number
    1219602-2011-00067
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 1, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOURCE OF THE METAL FRAGMENTS EXPERIENCED DURING USE, EMANATED FROM THE DISPLACED MATERIAL AT THE TIP OF THE INNER BLADE AND IS A FUNCTION OF GALLING OF THE INNER BLADE WITH THE OUTER BLADE. THE CAUSE OF THE GALLING IS DUE TO FORM OF THE RADIUS ON THE INNER BLADE TIP. ALTHOUGH THE RADIUS IS WITHIN DESIGN TOLERANCE, THE MATCH UP OF THE INNER RADIUS AND OUTER RADIUS CAUSED A DEGREE OF FRICTION. THIS ISSUE HAS BEEN RESOLVED WITH A TIGHTENED PROCESS TOLERANCE AND A DESIGN CHANGE TO THE INNER BLADE, ELIMINATING THE POTENTIAL FOR THIS FIT UP PROBLEM TO EXIST. (B)(4).

    Description of Event or Problem · 1

    WHEN USING THE INCISOR PLUS BLADE, METAL DUST STAYED BEHIND IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE STRAIGHT INCISOR BOXED INCISOR PLUS BL,(BX6) HAB SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7205345 50545511

    Patients

    Seq Age Sex Outcome Treatment
    1