BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI BEAVER6400

    MDR report key: 2971371 · Received February 4, 2013

    Report

    Report Number
    1211998-2013-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BECTON VISITEC INTERNATIONAL, INC.
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FINAL REPORT. BVI BECAME AWARE ON (B)(4) 2013 THAT AN INCIDENT OCCURRED ON (B)(6) 2012. THE INCIDENT OCCURRED IN (B)(6). (B)(6): (VERBATIM FROM REPORT): THE BLADE BROKE DURING AN ARTHROLYSIS SURGERY DEEPLY IN THE TISSUES. SEVERAL BLADES HAVE BEEN BROKEN WITH THE SAME MANNER. THE HANDLE IS A BEAVER ONE. THE RISK IS TO LET SOME PART OF THE BLADE INSIDE THE PATIENT BODY. THEY HAD TO INCISE AND SEARCH WITH ADDITIONAL EXAMINATIONS. BVI IS ATTEMPTING TO CONTACT THE CUSTOMER THROUGH OUR SALES REPRESENTATIVE IN (B)(6) FOR FURTHER INFORMATION. INVESTIGATION IS ONGOING AND BVI WILL PROVIDE FOLLOW UP REPORT ON OR ABOUT (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47487 BVI BEAVER6400 BEAVER MINI-BLADE GES BECTON VISITEC INTERNATIONAL, INC. NA 3016226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention