BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 4860870 · Received June 22, 2015

    Report

    Report Number
    0002936485-2015-00525
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COSMETIC APPEARANCE FAILURE MODE OF BLACK SPOTS COULD NOT BE CONFIRMED SINCE NO UNIT WAS RETURNED. MOST PROBABLE ROOT CAUSES ARE: 1. MANUFACTURING/ASSEMBLY ERROR, 2. INCORRECT OR INADEQUATE PACKAGING, 3. SEVERE SHIPPING CONDITIONS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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 BLACK SPOTS WERE NOTICED INSIDE THE PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SPOTS WERE NOTICED INSIDE THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404538 STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 15083SG2

    Patients

    Seq Age Sex Outcome Treatment
    1