BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOBBS MEDICAL POLYPECTOMY SNARE

    MDR report key: 13455585 · Received February 4, 2022

    Report

    Report Number
    1220592-2022-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 4, 2022
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    OCZ
    PMA / PMN Number
    K844074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE THIRD USE OF THE SAME MICRO OVAL LOOP POLYPECTOMY SNARE DURING A POLYPECTOMY, THE SNARE WAS UNABLE TO CUT THROUGH THE POLYP USING CAUTERY. IT APPEARS THAT THE WHITE PORTION AT THE START OF THE SHEATH GETS TWISTED AND BUNCHES UP. THIS SEEMS TO MAKE THE LOOP OF THE SNARE UNABLE TO FULLY CLOSE AND SECURE AROUND THE POLYP THEREFORE MAKING IT HARDER CUT THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588523 HOBBS MEDICAL POLYPECTOMY SNARE POLYPECTOMY SNARE OCZ HOBBS MEDICAL, INC. 4567OLY H02-20-093

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown