BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MICROAIRE MULTI-USE CANNULA

    MDR report key: 10848378 · Received November 16, 2020

    Report

    Report Number
    2020601-2020-00006
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 2, 2020
    Report Date
    November 19, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    MUU
    PMA / PMN Number
    K171286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REFERRENCE ATTACHED DOCUMENT FAILURE ANALYSIS 2020601-2020-00006.

    Additional Manufacturer Narrative · 1

    PART NUMBER AND LOT NUMBER IS UNKNOWN AT THIS TIME. MICROAIRE IS ANTICIPATING THE COMPLAINT PRODUCT TO BE RECEIVED FOR EVALUATION AND THIS RECORD WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    A CUSTOMER HAS REPORTED THAT DURING A LIPOSUCTION PROCEDURE A MICROAIRE BRANDED CANNULA WAS BEING USED TO HARVEST FAT FROM A PATIENT'S ARM. WHEN THE CANNULA WAS REMOVED AT THE COMPLETION OF THE PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE CANNULA WAS BROKEN AND RETAINED WITHIN THE PATIENT'S ARM. AN X-RAY C-ARM MACHINE WAS USED TO LOCATE THE CANNULA FRAGMENT. THE BROKEN TIP OF THE CANNULA WAS RETRIEVED, AND THE PATIENT WAS STABLE FOR DISCHARGE. IT IS NOTED THAT THE PATIENT HAS AN ADDITIONAL SCAR AS A RESULT OF EXTRACTING THE CANNULA TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307150 MICROAIRE MULTI-USE CANNULA 4.00MM MULTI-USE CANNULA MUU MICROAIRE SURGICAL INSTRUMENTS, LLC PAL-R407LL 0420349392

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR