BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE MULTI-USE CANNULA

    MDR report key: 10864263 · Received November 18, 2020

    Report

    Report Number
    2020601-2020-00005
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    MUU
    PMA / PMN Number
    K171286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE DOCUMENT FAILURE ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A MICROAIRE MULTI-USE CANNULA HAS BROKEN DURING A CASE ON (B)(6)2020. ON (B)(6) 2020, MICROAIRE WAS NOTIFIED THAT IT WAS NECESSARY TO PERFORM AN AMBULATORY SURGERY THE DAY AFTER THE INITIAL SURGERY TO EXTRACT THE TIP OF THE CANNULA. THE PATIENT WAS STABLE AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328723 MICROAIRE MULTI-USE CANNULA 4.0MM MULTI-USE CANNULA MUU MICROAIRE SURGICAL INSTRUMENTS, LLC PAL-R407LL 0117302493

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR