BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE CANNULAS -

    MDR report key: 1891754 · Received November 5, 2010

    Report

    Report Number
    1219602-2010-00273
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THESE CANNULAS HAVE 'ROUGH DISTAL ENDS' AND HAVE CAUSED SEVERAL CASES OF UNINTENTIONAL CARTILAGE DAMAGE. WHEN FOLLOWING UP WITH THE REP TO QUANTIFY THE TOTAL INCIDENTS, HE STATED "IT HAS HAPPENED AT LEAST 15 TIMES (TWO OTHER COMPLAINTS HAVE BEEN OPENED). THE CARTILAGE LOOKED "DENTED" OR SCUFFED. THEY HAVE NOT HAD TO DO ANY MAJOR REPAIR OTHER THAN RESECTING AND SMOOTHING THE ROUGH AREA. THIS COMPLAINT IS BEING OPENED TO CAPTURE THE 13 ADDITIONAL REPORTED TIMES THIS ISSUE HAS OCCURRED. LOTS: 50340376; 50338077 AND 50342138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE CANNULAS - CANN, H.F.,DGNST, 6MM, RTBL NBH SMITH & NEPHEW ENDOSCOPY 72200829

    Patients

    Seq Age Sex Outcome Treatment
    1