BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 1911301 · Received November 22, 2010

    Report

    Report Number
    2648666-2010-00461
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE UNIT SHED METAL FLAKES INTO THE JOINT OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE UNIT WAS SO COMPLETELY OUT OF SPEC THAT THE INNER BLADE INTERSECTED THE OUTER BLADE. THE CASE WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10236CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK