BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRETT V2 I/A TIP, BENT, 0.3 MM PORT

    MDR report key: 2604312 · Received June 4, 2012

    Report

    Report Number
    3019924-2012-00020
    Event Type
    Injury
    Date Received
    June 4, 2012
    Report Date
    June 4, 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 BURRS OR GOUGES. THE REMAINDER OF THE TIP IS IN VERY GOOD CONDITION, LIKE NEW CONDITION AS WELL. THE DEVICE WAS MANUFACTURED IN 04/01/2012 AND A REVIEW OF THE DHR (BHR) DEMONSTRATED NO UNUSUAL MFG ISSUES OR NONCONFORMITIES.

    Description of Event or Problem · 1

    A PT EXPERIENCED A POSTERIOR CAPSULE TEAR DURING A SURGEON EVALUATION OF A BARRETT V2 I/A TIP, (B)(4). AN MST SALES REP, IN ATTENDANCE, STATED THAT THE SURGEON REPORTED THAT THE PT EXPERIENCED A POSTERIOR CAPSULE TEAR JUST AFTER THE BARRETT TIP WAS PLACED AGAINST THE POSTERIOR CAPSULE. THE SURGEON STATED THAT THE DEVICE APPEARED SHARP WHICH RESULTED IN THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRETT V2 I/A TIP, BENT, 0.3 MM PORT IRRIGATION/ASPIRATION TIP HQE MICROSURGICAL TECHNOLOGY, INC. BRT-1034-B 045993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention