BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOBBS MEDICAL POLYPECTOMY SNARE

    MDR report key: 24003356 · Received January 8, 2026

    Report

    Report Number
    1220592-2026-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    November 26, 2025
    Report Date
    January 8, 2026
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    KNS
    PMA / PMN Number
    K844074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIRST REPORT OF THIS TYPE OF FAILURE REPORTED IN THE LAST 10 YEARS, AT LEAST. CONFIRMED OTHER UNITS FROM THIS LOT HAD BEEN USED SUCCESSFULLY BY THIS FACILITY PRIOR TO THE DATE OF THE CURRENT REPORTED INCIDENT. DHR REVIEW WAS PERFORMED BUT DID NOT IDENTIFY ANY ERRORS IN MANUFACTURE, INSPECTION/TESTING, OR RELEASE OF THE SUBJECT LOT. NO RETESTING COULD BE PERFORMED AS NO UNITS OF THE SUBJECT LOT REMAIN ON-HAND AT HOBBS MEDICAL, AND THE SUBJECT DEVICES WERE DISCARDED BY THE HEALTHCARE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 SNARES WITHIN THE SAME LOT NUMBER MISFIRED. THE MECHANISM IN THE HANDLE SEEMED TO BREAK AFTER OPENING AND CLOSING. THE DEVICE WAS BEING USED IN DURING AN ENDOSCOPIC PROCEDURE. THERE WAS NO PATIENT HARMED REPORTED AND COMPLAINT ITEMS WERE NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65487 HOBBS MEDICAL POLYPECTOMY SNARE POLYPECTOMY SNARE KNS HOBBS MEDICAL, INC. H08-24-258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown