BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRETT V2 I/A TIP, STRAIGHT 0.3MM PORT

    MDR report key: 2621607 · Received June 14, 2012

    Report

    Report Number
    3019924-2012-00024
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 13, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HQE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS CLEAN AND HAD NO APPARENT DAMAGE WHEN INSPECTED WITH THE NAKED EYE. INSPECTION AT 40X DEMONSTRATED THAT THE PORT IS WELL SHAPED WITH NO DEFECTS. THE REMAINDER OF THE TIP IS IN VERY GOOD CONDITION AND MEETS FINAL ACCEPTANCE CRITERIA. THERE ARE SEVERAL SMALL SMOOTH SPOTS IN THE SAND BLASTED SURFACE BUT THERE ARE NO HOLES OR ROUGHENED DAMAGE.

    Description of Event or Problem · 1

    AN (B)(4) SALES REP REPORTED A SERIOUS PT INJURY WHEN A SURGEON WAS POLISHING A POSTERIOR CAPSULE WITH A BARRETT V2 IRRIGATION/ASPIRATION TIP, BRT-1033-B, STRAIGHT, CAPSULE POLISH, 0.3 MM PORT. THE SURGEON WAS REQUIRED TO PERFORM AN ANTERIOR VITRECTOMY, PLACE AN IMPLANTED IOL IN THE SULCUS, AND CLOSE THE PARACENTESIS WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRETT V2 I/A TIP, STRAIGHT 0.3MM PORT IRRIGATION/ASPIRATION TIP HQE MICROSURGICAL TECHNOLOGY, INC. BRT-1033-B 045993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention