BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8301, S ALEXIS WND PROT/RET 5/BX

    MDR report key: 6985676 · Received October 27, 2017

    Report

    Report Number
    2027111-2017-02092
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    January 18, 2017
    Report Date
    October 27, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117207
    PMA / PMN Number
    K041711
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE EVENT UNIT AND THE COMPLAINANT'S EXPERIENCE OF THE RING SEPARATING FROM THE SHEATH COULD NOT BE CONFIRMED. HOWEVER, ENGINEERING FOUND FOUR (4) SMALL HOLES AND A LARGE HORIZONTAL TEAR IN THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE TEAR WAS CAUSED BY AN INSTRUMENT THAT PUNCTURED THE SHEATH DURING THE PROCEDURE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. THIS REPORT REPRESENTS THE INITIAL AND FINAL REPORT. BASED ON THE DESCRIPTION OF THE EVENT RECEIVED, THE EVENT WAS DEEMED NOT REPORTABLE AS IT POSES MINIMAL RISK TO THE PATIENT. AFTER EVALUATION, THE EVENT IS DEEMED REPORTABLE.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: "THE SHEATH WAS SEPARATED FROM THE RING." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SALES MANAGER, ON THURSDAY (B)(6) 2017: " THE SHEATH ON THE WHITE RING SIDE WAS SEPARATED FROM THE RING IN PLACES. THE SEPARATED BEFORE USE AFTER UNPACKING. IT WAS NOT INSERTED AFTER NOTICING THIS." TYPE OF INTERVENTION: UNKNOWN PATIENT STATUS: "NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762701 C8301, S ALEXIS WND PROT/RET 5/BX KGW KGW APPLIED MEDICAL RESOURCES C8301 1263157 00607915117207

    Patients

    Seq Age Sex Outcome Treatment
    1