BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    MDR report key: 3933557 · Received July 15, 2014

    Report

    Report Number
    0002936485-2014-00501
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN MATERIAL FAILURE MODE WAS CONFIRMED ON THE PRODUCT RECEIVED. LIKELY ROOT CAUSES ARE: MANUFACTURING/ASSEMBLY ERROR, INCORRECT OR INADEQUATE PACKAGING, SEVERE SHIPPING CONDITIONS, 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 UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    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 UPON OPENING THE PACKAGING THE TUBING WAS DIRTY AND A WHITE POWDERY RESIDUE WAS SEEN ON THE IRRIGATION TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGING THE TUBING WAS DIRTY AND A WHITE POWDERY RESIDUE WAS SEEN ON THE IRRIGATION TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413656 STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 14132FG2

    Patients

    Seq Age Sex Outcome Treatment
    1