BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFIRE CONSOLE

    MDR report key: 1933137 · Received December 13, 2010

    Report

    Report Number
    2936485-2010-00918
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 THE RUBBER TIP OF THE UNIT BEGAN TO MELT WHEN IT WAS SWITCHED TO MAXIMUM SETTINGS DURING A CASE. IT WAS FURTHER REPORTED THAT A SECOND UNIT WAS USED AND THE SAME MELTING FAILURE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK