BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRAVISION URETERAL KIT

    MDR report key: 1051895 · Received May 22, 2008

    Report

    Report Number
    2936485-2008-00046
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED, ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFRAVISION URETERAL KIT WAS NOT LIGHTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRAVISION URETERAL KIT URETERAL KIT EZN STRYKER ENDOSCOPY SAN JOSE 000522

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK