BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCONTROL

    MDR report key: 2120424 · Received May 27, 2011

    Report

    Report Number
    2936485-2011-00355
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    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 THE DEVICE WAS USED DURING A SURGERY AND IT WAS NOT WORKING AT ALL. IT WAS FURTHER REPORTED THAT THE ALIGNMENT WAS IMPOSSIBLE TO PERFORM. IT WAS THEN DECIDED THAT THE SURGERY NEEDED TO BE POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCONTROL FLOCONTROL HRX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK