BEUDAMED
    FDA Adverse Event Other Summary report: N

    BVI BEAVER6900

    MDR report key: 2845057 · Received November 7, 2012

    Report

    Report Number
    1211998-2012-00008
    Event Type
    Other
    Date Received
    November 7, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BEAVER VISITEC INTERNATIONAL, INC.
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEER AT BVI, (B)(4), SPOKE TO (B)(6) ON (B)(4) 2012. THE CHANGE TO THE TRAY WITH INSTRUCTIONS WAS PROVIDED TO THE SITE, HOWEVER, SHE NEVER RECEIVED THIS INFORMATION PERSONALLY. (B)(4) WALKED HER THROUGH THE ONLINE ASSEMBLY VIDEO. (B)(6) COULD NOT EXPLAIN TO (B)(4) WHY THE NURSE PUSHED THE HANDLE/BLADE TOWARDS HER HAND WHEN THE PICTURES ONLY SHOW TO TURN THE HANDLE CLOCKWISE TO ENGAGE THE THREADS AND THEN UP TO REMOVE THE BLADE FROM THE TRAY. (B)(6) EXPLAINED THAT SHE WANTED TO PROVIDE BVI FEEDBACK, SO THAT IT DOESN'T HAPPEN TO ANYONE ELSE. BVI WALKED THROUGH THE INSTRUCTION VIDEO WITH SITE AND NOTED THEIR CONCERNS ABOUT THE INSTRUCTIONS. BVI HAS NOT HAD THIS TYPE OF ISSUE PRIOR TO LEARNING OF THIS INCIDENT. IN ADDITION, CONTRARY TO WHAT WAS COMMUNICATED TO BVI, PICTORIAL INSTRUCTIONS ARE INCLUDED ON EVERY BOX RECEIVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    FINAL REPORT. BVI BECAME AWARE ON (B)(4) 2012 THAT AN INCIDENT OCCURRED (DATE UNKNOWN). BVI BECAME AWARE THAT A MEDWATCH REPORT ((B)(4)) WAS FILED FROM A LETTER FROM FDA, DATED (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVI BEAVER6900 BEAVER MINI-BLADE GES BEAVER VISITEC INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention