BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRAVISION URETERAL KIT

    MDR report key: 2070381 · Received April 18, 2011

    Report

    Report Number
    2936485-2011-00239
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ONE OF THE BLACK MARKERS ON THE UNIT CAME OFF AND ENDED UP IN THE BLADDER OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO RETRIEVE THE MARKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRAVISION URETERAL KIT CATHETER EZN STRYKER ENDOSCOPY SAN JOSE PSTR11510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK