BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., SDC ULTRA

    MDR report key: 1621846 · Received February 5, 2010

    Report

    Report Number
    2936485-2009-00437
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 14, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    LMD
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 07/01/2006 TO 07/01/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B)(4). THERE ARE 1 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE LMB.

    Description of Event or Problem · 1

    INCORRECT DATA SAVED. IF TWO PATIENT ARE LOADED IN THE TO DO LIST, WHEN THE IMAGES ARE SAVED, THE INCORRECT PATIENT DATA IS BEING SAVED WITH THE IMAGES. EXAMPLE: PATIENT ONE'S PICTURES ARE GETTING PATIENT 2'S DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG., SDC ULTRA INSTRUMENT LMD STRYKER ENDOSCOPY SAN JOSE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA