BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER STRYKEFLOW II SUCTION IRRIGATOR

    MDR report key: 371088 · Received January 7, 2002

    Report

    Report Number
    2936485-2001-00044
    Event Type
    Other
    Date Received
    January 7, 2002
    Date of Event
    November 29, 2001
    Report Date
    December 7, 2001
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE UNIT CONTINUED SUCTIONING AFTER THE BUTTON WAS RELEASED. THE DOCTOR SET THE END OF THE UNIT ON THE PT AND CAUSED A HEMATOMA ON THE PT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER STRYKEFLOW II SUCTION IRRIGATOR SUCTION IRRIGATOR HRX STRYKER ENDOSCOPY 0250-070-500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other