BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 2844762 · Received November 1, 2012

    Report

    Report Number
    1037905-2012-00610
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 5, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC W2971724

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST