BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ENGINE CANISTER

    MDR report key: 8745800 · Received June 28, 2019

    Report

    Report Number
    3005168196-2019-01277
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 30, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT A PENUMBRA ENGINE (ENGINE) WAS LOSING SUCTION WHILE IN USE WITH A PENUMBRA ENGINE CANISTER (CANISTER). THE MALFUNCTION WAS FOUND PRIOR TO USE AND, THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ENGINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538738 PENUMBRA ENGINE CANISTER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1