BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23 GAUGE POSTERIOR VITRECTOMY PACK

    MDR report key: 2670218 · Received July 20, 2012

    Report

    Report Number
    1920664-2012-00146
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 23 GAUGE VITRECTOMY CUTTER WAS REC'D WITH OUT THE ORIGINAL PACKAGING. THE PART NUMBER AND LOT NUMBER COULD NOT BE VERIFIED. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE DID NOT APPEAR TO BE BENT. THE PORT WINDOW WAS IN THE OPENED CONDITION AND THERE WAS FLUID IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE ON THE SIDE OF THE CUTTER BODY. THE TUBING HAD BEEN REMOVED FROM THE CUTTER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED PRODUCT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM A USER FACILITY IN THE USA STATING: "DURING VITRECTOMY, THERE MAY HAVE BEEN A CLOG OR OCCLUSION IN THE TUBING WHICH LED THE SURGEON, DR. (B)(6), TO CONCLUDE THE CUTTING ACTION HAD STOPPED. WHEN THE CLOG WAS CLEARED THERE WAS AN INCREASE IN ASPIRATION WHICH MAY HAVE CAUSED TRACTION ON THE RETINA. THE CUTTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO DAMAGE TO THE RETINA OR ANY OTHER INJURY TO THE PT. THE PT OUTCOME WAS GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS 23 GAUGE POSTERIOR VITRECTOMY PACK HQC BAUSCH & LOMB U8042

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSCH & LOMB)