BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITRECTOMY CUTTER

    MDR report key: 3221852 · Received July 9, 2013

    Report

    Report Number
    1920664-2013-00154
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. ONE 25GA CUTTER WAS RETURNED IN PLASTIC ZIP LOCK BAG WITHOUT THE ORIGINAL PACKAGING. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT APPROX 15 DEGREES OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. A FUNCTIONAL TEST WAS PERFORMED AT VARIOUS CUT RATES AND ASPIRATION LEVELS USING A STELLARIS PC SYSTEM. THE INNER NEEDLE ADVANCED ONLY TO APPROX THE CENTER OF THE PORT WINDOW NEVER REACHING THE CUTTING EDGE. THE CUTTER CANNOT CUT IN THIS CONDITION. IT SHOULD BE NOTED THAT A BENT NEEDLE COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE CAUSE OF THE BENT NEEDLE CONDITION CANNOT BE DETERMINED. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER STOPPED CUTTING DURING THE SURGICAL PROCEDURE. A BACK UP PACK WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312668 STELLARIS 25G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5625 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1