BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFIRE CONSOLE KIT

    MDR report key: 2133286 · Received May 12, 2011

    Report

    Report Number
    2936485-2011-00313
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE PRODUCT CAUSED DAMAGE TO 2 SCOPES DURING USE. IT WAS FURTHER REPORTED THAT THIS CAUSED A DELAY OF 30 MINS TO THE CASE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSFIRE CONSOLE KIT CONSOLE GEI STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK