BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23GA POSTERIOR PACK W AFI & WF

    MDR report key: 3070528 · Received April 17, 2013

    Report

    Report Number
    1920664-2013-00096
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    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

    EVALUATION COMPLETED. ONE OPENED BL5423W PACK FROM LOT U7595 WAS RETURNED. THE PACK CONTAINS ONE 23GA CUTTER. THE TUBING WAS STILL COILED AND TAPED TOGETHER. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT/CURVED APPROXIMATELY 10 DEGREES OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION WITH DEBRIS VISIBLE INSIDE. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER WAS TESTED AT VARIOUS CUT RATES FROM 2000 - 5000 C.P.M. THE CUTTER CANNOT CUT AS THE INNER NEEDLE WILL NOT MOVE/ACTUATE. THE CUTTER IS CLOGGED AND CANNOT ASPIRATE. IT SHOULD BE NOTED THAT A BENT NEEDLE CONDITION COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. IT CANNOT BE DETERMINED WHEN THE BENT NEEDLE AND CLOGGED CONDITIONS OCCURRED. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 4. SEE 1920664-2013-00095, 00097, AND 00098.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER HAD INADEQUATE CUTTING ACTION DURING SURGERY. THE FACILITY COULD NOT PROVIDE THE DATE OF THE EVENT. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165193 STELLARIS 23GA POSTERIOR PACK W AFI & WF HQC BAUSCH & LOMB, INC. BL5423W U7595

    Patients

    Seq Age Sex Outcome Treatment
    1