BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOBBS MEDICAL POLYPECTOMY SNARE

    MDR report key: 14370907 · Received May 12, 2022

    Report

    Report Number
    1220592-2022-00002
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 12, 2022
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    OCZ
    PMA / PMN Number
    K844074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A LAPAROSCOPIC ASSISTED G TUBE PROCEDURE, THE FIRST SNARE WOULD NOT OPEN OR CLOSE. THE SECOND SNARE WOULD NOT CLOSE ALL THE WAY TO GRAB THE G TUBE AND FELLOW HAD TO MANUALLY PUT THE SNARE OUT. NO APPARENT HARM TO PATIENT, ALTHOUGH MALFUNCTION WAS INCONVENIENT, AND PROCEDURE WAS PERFORMED AS BOOKED AS STAFF WAS ABLE TO PULL SNARE OUT MANUALLY. REPORTER INDICATED THE ISSUE IS RECURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171419 HOBBS MEDICAL POLYPECTOMY SNARE POLYPECTOMY SNARE, SINGLE-USE OCZ HOBBS MEDICAL, INC. 7202 H04-19-056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown