BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 3973900 · Received August 1, 2014

    Report

    Report Number
    0002936485-2014-00549
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 8, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE FOREIGN MATERIAL CONDITION WAS CONFIRMED ON THE RETURNED UNIT.LIKELY ROOT CAUSES ARE: 1. MANUFACTURING/ASSEMBLY ERROR, 2. INCORRECT OR INADEQUATE PACKAGING, 3. SEVERE SHIPPING CONDITIONS, 4. USER ERROR IN NOT PROPERLY INSPECTING UNIT PRIOR TO USE, AS PER RISK DOCUMENTS. WE CONCLUDED THE MOST PROBABLE ROOT CAUSES TO BE: SEVERE SHIPPING CONDITIONS DUE TO VISUAL INSPECTION, INVESTIGATION FINDINGS AND RISK DOCUMENTS.IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE STERILE PACKAGING, A WHITE POWDERY SUBSTANCE WAS FOUND ON THE DISPOSABLE TIP OF THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE STERILE PACKAGING, A WHITE POWDERY SUBSTANCE WAS FOUND ON THE DISPOSABLE TIP OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450831 STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 13176FG2

    Patients

    Seq Age Sex Outcome Treatment
    1