BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS LARIAT

    MDR report key: 15156136 · Received August 2, 2022

    Report

    Report Number
    MW5111242
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 1, 2022
    Manufacturer
    STERIS / ISOMEDIX OPERATIONS INC.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD TRYING TO REMOVE LARGE GASTRIC POLYP WITH SNARE CAUTERY AND CAUTERY DID NOT WORK WITH THE SNARE. SNARE IS STERIS LARIAT LOT #2201659. IT IS NOT EXPIRED BUT WE HAVE NOTICED THE HANDLE LOOKS YELLOWED. THE SNARE GOT STUCK ON THE POLYP AND WE HAD TO CUT IT REMOVING THE HANDLE TO GET THE SCOPE OUT OF THE PATIENT. WE USED ANOTHER SNARE TO REMOVE THE FIRST SNARE AND DID NOT REMOVE THE POLYP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162686 STERIS LARIAT SNARE, FLEXIBLE FDI STERIS / ISOMEDIX OPERATIONS INC. 2201659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other