BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET 19G CURVED ASPIRATION .4MM PORT

    MDR report key: 4332007 · Received December 4, 2014

    Report

    Report Number
    3019924-2014-00053
    Event Type
    Injury
    Date Received
    December 4, 2014
    Report Date
    December 2, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION PERFORMED SHOWED THAT THE RETURNED TIP WAS WITHIN SPECIFICATION AND FREE OF ANY SHARP EDGES OR BURRS. THE CAUSE OF THE CAPSULE BREAK IS UNKNOWN. THE FACILITY REPORTED THAT THERE WERE THREE CAPSULE BREAKS INVOLVING TWO SEPARATE TIPS. THIS IS THE FIRST OF TWO REPORTS.

    Description of Event or Problem · 1

    WHILE USING AN MST DUET BI-MANUAL ASPIRATION TIP TO PERFORM THE CAPSULE POLISH PORTION OF A CATARACT SURGERY, THE SURGEON EXPERIENCED A CAPSULE TEAR. A VITRECTOMY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT'S PROGNOSIS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782448 DUET 19G CURVED ASPIRATION .4MM PORT ASPIRATION TIP HMX MICROSURGICAL TECHNOLOGY, INC. DU-02341X1 063727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention