BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23GA POSTERIOR PACK

    MDR report key: 3221839 · Received July 9, 2013

    Report

    Report Number
    1920664-2013-00156
    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 COLLECTION CASSETTE ASSEMBLY WITH A 20GA CUTTER WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS NOT BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. CLOSE VISUAL INSPECTION FOUND THAT THE AIR LINE (THE DRIVE CONNECTION DAMPENER AND BARB CONNECTOR) IS NOT FULLY SEATED INTO THE BACK CAP. FUNCTIONAL TESTING WAS PERFORMED USING A STELLARIS PC SYSTEM. THE AIR LINE DID POP OUT DURING TESTING CAUSING LOSS OF CUTTING ACTION. THE CUTTER CANNOT FUNCTION IN THIS CONDITION. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING THE VITRECTOMY PROCEDURE, THE TUBING PROVIDING AIR EXCHANGE DISCONNECTED FROM THE CUTTER. 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
    312552 STELLARIS 23GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. BL5220W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1