BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 2142968 · Received June 21, 2011

    Report

    Report Number
    2648666-2011-00158
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WHITE POWDERY SUBSTANCE WAS FOUND ON THE SUCTION IRRIGATOR WHEN OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) STRYKEFLOW GCX STRYKER ENDOSCOPY PUERTO RICO TBA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK