BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 4221467 · Received November 3, 2014

    Report

    Report Number
    0002936485-2014-00866
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TIP DEFECTS CONDITION WAS CONFIRMED ON THE PRODUCT RECEIVED. UPON DEVICE INSPECTION IT WAS NOTED THAT WHAT IS REFERRED TO AS A TIP DEFECT IS THE EFFECT OF THE METAL TIP RUBBING AGAINST THE TUBING OR OTHER DEVICE PARTS MOST LIKELY DURING SHIPPING TRANSIT AND HANDLING. THIS IS A KNOWN DEFECT THAT OCCURS MOSTLY DURING ROUGH HANDLING AND SHIPPING CONDITIONS THAT FORCES THE METAL TIP TO HIT AND/OR RUB AGAINST OTHER COMPONENTS. THIS FAILURE MODE IS EASILY REPLICATED BY RUBBING THE METAL TIP AGAINST THE TUBING AND OTHER DEVICE PARTS. THIS IS ALSO EASILY NOTICEABLE. THE PROBABLE 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, WITH THE EVIDENCE AT HAND, THE MOST LIKELY ROOT CAUSE IS SEVERE SHIPPING CONDITIONS. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT MIGHT NOT BE STERILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT MIGHT NOT BE STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701390 STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 14199FG2

    Patients

    Seq Age Sex Outcome Treatment
    1