BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW II

    MDR report key: 2170988 · Received July 15, 2011

    Report

    Report Number
    2170988
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE STRYKER DISPOSABLE SUCTION/IRRIGATORS FAILED DURING A CASE. THERE WAS BLEEDING AND THE SUCTION DID NOT WORK. OUR ENTIRE INVENTORY WAS THE SAME LOT NUMBER. REFERENCE NUMBER IS 250-070-500 AND LOT NUMBER IS 11164FG2. THE MANUFACTURER SALES REPRESENTATIVE AND THE DISTRIBUTOR WERE NOTIFIED. A SHIPMENT WILL BE HERE TONIGHT WITH A DIFFERENT LOT NUMBER. THERE WERE NO COMPLICATIONS DOCUMENTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II DISPOSABLE SUCTION/IRRIGATORS GCX STRYKER ENDOSCOPY 205-070-500 11164FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR