BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22G CURVED ASPIRATOR, .3 MM PORT

    MDR report key: 4193813 · Received October 9, 2014

    Report

    Report Number
    3019924-2014-00045
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS NOT "DIAMOND DUSTED". MST DOES NOT MANUFACTURE DIAMOND DUSTED TIPS. THE RETURNED TIP WAS A CAPSULE POLISHED BI-MANUAL ASPIRATION TIP THAT SHOWED NORMAL SIGNS OF USE; HOWEVER, DID NOT HAVE ANY LOOSE PARTICULATE OR RESIDUE THAT COULD HAVE BEEN INTRODUCED INTO THE EYE. IT IS MOST LIKELY THAT THE DEBRIS WAS SURGICAL RESIDUE FROM PREVIOUS USE THAT WAS NOT THOROUGHLY CLEANED FROM THE TIP.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT "DIAMOND PARTICLES WERE VISIBLE IN THE ANTERIOR CHAMBER AFTER USING THE DIAMOND DUSTED ASPIRATION TIP". THIS WAS ALLEGED TO HAVE CAUSED PROLONGED INFLAMMATION IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636842 22G CURVED ASPIRATOR, .3 MM PORT BIMANUAL ASPIRATION TIP CAZ MICROSURGICAL TECHNOLOGY, INC. DU-02355

    Patients

    Seq Age Sex Outcome Treatment
    1