BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 1883269 · Received October 20, 2010

    Report

    Report Number
    2648666-2010-00431
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE UNIT'S TRIGGER GOT STUCK RESULTING IN EXCESSIVE SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) STRYKEFLOW2 GCX STRYKER ENDOSCOPY PUERTO RICO 10252FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK