BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 2133233 · Received May 10, 2011

    Report

    Report Number
    2648666-2011-00132
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT FAILED. IT WAS FURTHER REPORTED THAT IT WAS DURING A CASE AND THAT THE BLUE BUTTON BROKE OFF. FURTHER, THE PT'S PROCEDURE WAS COMPLETED SUCCESSFULLY AND AT THIS TIME, THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) STRYKEFLOW GCX STRYKER ENDOSCOPY PUERTO RICO 11069FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK