BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 2861805 · Received November 7, 2012

    Report

    Report Number
    2648666-2012-00352
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K941333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GREEN FILM WAS FOUND ON THE SHAVER BLADE UNIT. THE FILM WENT INTO THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) HRX STRYKER ENDOSCOPY PUERTO RICO 12235CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK