BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI AND FF 6/BX

    MDR report key: 4219269 · Received October 28, 2014

    Report

    Report Number
    1920664-2014-00224
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED RECEIVED ONE (B)(6)PACK FROM LOT V2979. THIS PACK CONTAINS A 25GA VITRECTOMY CUTTER WAS ATTACHED TO THE ASPIRATION PORT OF THE COLLECTION CASSETTE, AS IT SHOULD BE. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS NOT BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS FLUID IN THE LINES. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE INNER NEEDLE DOES NOT ALWAYS REACH THE CUTTING EDGE. THE CUTTER PULLED AND LEFT STRINGS. THE CUTTER BECAME CLOGGED DURING FUNCTIONAL TESTING AND COULD NOT BE CLEARED. THIS CUTER WAS NOT FUNCTIONING AS INTENDED. IT SHOULD BE NOTED THAT A BENT NEEDLE CONDITION COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE CAUSE OF THE BENT NEEDLE CANNOT BE DETERMINED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 3. SEE 1920644-2014-00219 AND 00225.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING AT 4000 CPM, AND WOULD NOT ASPIRATE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690262 STELLARIS 25GA POSTERIOR PACK W AFI AND FF 6/BX 25GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. V2979

    Patients

    Seq Age Sex Outcome Treatment
    1