BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 1589592 · Received January 21, 2010

    Report

    Report Number
    MW5014535
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 20, 2010
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRYKER SUCTION IRRIGATOR DID NOT FUNCTION - OUT OF THE BOX. THE UNIT WOULD NOT ENGAGE. THERE WERE NO ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY DISPOSABLE SUCTION IRRIGATOR HRX 250-070-500 09364FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other