BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1288HD CAMERA CONTROL UNIT

    MDR report key: 2946208 · Received January 4, 2013

    Report

    Report Number
    2936485-2013-90010
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 USER EXPERIENCED COLOR INTERFERENCE WITH THE DEVICE DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5762 1288HD CAMERA CONTROL UNIT FWB STRYKER ENDOSCOPY SAN JOSE 10A015534

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK