BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1088 HD CAMERA CONTROL UNIT

    MDR report key: 1894204 · Received November 2, 2010

    Report

    Report Number
    2936485-2010-00809
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WENT OUT DURING A CASE, CAUSING A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1088 HD CAMERA CONTROL UNIT CAMERA FWF STRYKER ENDOSCOPY SAN JOSE 04J007724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK