BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKERFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 2000651 · Received February 3, 2011

    Report

    Report Number
    2648666-2011-00025
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIQUID SUBSTANCE LEAKED FROM THE UNIT. IT WAS FURTHER REPORTED THAT THIS WAS THE THIRD TIME THIS HAD HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKERFLOW2 WITH DISPOSABLE TIP (6BX) SUNCTION/IRRIGATION GCX STRYKER ENDOSCOPY PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK