BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED SINGULAR POLYECTOMY SNARE MEDIUM OVAL

    MDR report key: 1025048 · Received April 3, 2008

    Report

    Report Number
    MW5006144
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 3, 2008
    Manufacturer
    CONMED
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILIARY STENT WAS ATTEMPTED TO BE REMOVED BY CONMED SINGULAR POLYPECTOMY SNARE MEDIUM OVAL, LOT REF #000983, LOT 0709213. FIRST ATTEMPT THE WIRE SNARE BROKE INSIDE THE PT. SNARE WAS RETRIEVED INTACT. SECOND ATTEMPT WITH ANOTHER SNARE WITH THE SAME LOT # 0709213 SNARE LOOP DETACHED FROM THE DEVICE INSIDE THE PT. THE DETACHED LOOP AND SNARE WAS RETRIEVED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SINGULAR POLYECTOMY SNARE MEDIUM OVAL NONE FDI CONMED 0709213

    Patients

    Seq Age Sex Outcome Treatment
    1