BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G POST VITRECTOMY PACK W WF

    MDR report key: 4102334 · Received August 27, 2014

    Report

    Report Number
    1920664-2014-00158
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE 23GA VITRECTOMY CUTTER WAS RETURNED IN A SMALL PLASTIC ZIP LOCK BAG. THE ORIGINAL PACKAGING WAS NOT RETURNED. A PHOTOCOPY OF THE PACK LABEL INDICATES IT WAS A BL5223W PACK FROM LOT V2903. THE TIP PROTECTOR AND THE TUBING WERE NOT RETURNED. THE NEEDLE WAS BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE PORT AND ON THE OUTER NEEDLE SHAFT. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER HAD GOOD CLEAN CUTS THROUGHOUT THE VARIOUS CUT RATES AND ASPIRATED AS INTENDED. HOWEVER, SINCE THE TUBING WAS NOT RETURNED IT CANNOT BE DETERMINED IF THERE WERE DEFECTS IN THE TUBING OR CONNECTORS THAT COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 2 SEE 1920664-2014-00159.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522711 STELLARIS 25G POST VITRECTOMY PACK W WF 25G POST VITRECTOMY PACK HQC BAUSCH & LOMB, INC. V2903

    Patients

    Seq Age Sex Outcome Treatment
    1