BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25 GAUGE POSTERIOR VITRECTOMY PACK

    MDR report key: 2113835 · Received May 17, 2011

    Report

    Report Number
    1920664-2011-00040
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CUTTER WAS RECEIVED IN A PLASTIC SEALED BAG WITHOUT THE TIP PROTECTOR. VISUAL INSPECTION FOUND THE NEEDLE IS BENT AND THE PORT WINDOW IS IN THE OPENED POSITION. FLUID WAS OBSERVED IN THE ASPIRATION LINE. ADDITIONAL TESTING WILL BE CONDUCTED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE CUTTER ASSEMBLY, CONTAINED WITHIN THE STELLARIS 25 GAUGE POSTERIOR VITRECTOMY PACK IS MANUFACTURED BY MIDLABS. THE MANUFACTURER HAS BEEN CONTACTED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN THE USA STATING: "GUILLOTINE WOULD NOT MOVE UP AND DOWN. THE POWER AND SUCTION WERE OPERATING PROPERLY. THE PORT WAS OPEN. A BACKUP CUTTER WAS USED TO COMPLETE THE PROCEDURE." THERE WAS NO SERIOUS INJURY OR REPORT OF PERMANENT IMPAIRMENT REPORTED RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS 25 GAUGE POSTERIOR VITRECTOMY PACK HQC BAUSCH & LOMB U4663

    Patients

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