BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 3070403 · Received April 17, 2013

    Report

    Report Number
    1920664-2013-00082
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    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 OPENED BL5623 POUCH FROM LOT U8737 WAS RETURNED IN A PLASTIC BIOHAZARD ZIP LOCK BAG. THE POUCH CONTAINS ONE 23GA CUTTER. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE IS SLIGHTLY BENT APPROXIMATELY 5 DEGREES OR LESS. THE PORT WINDOW IS IN THE OPENED POSITION. THERE IS FLUID IN THE ASPIRATION LINE. THE BACK CAP IS OFF CENTER OF THE VENT HOLE IN THE SIDE OF THE CUTTER BODY BY APPROXIMATELY 5 DEGREES. THE CONNECTIONS ARE TIGHT AS THEY SHOULD BE. THERE ARE NO VISIBLE CRACKS OR DEFECTS IN THE LURE CONNECTORS. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE ASSEMBLY HAD GOOD CLEAN CUTS AT VARIOUS CUT RATES AND THE CUTTER ASPIRATED AS REQUIRED. THE CUSTOMER ALSO RETURNED AN UNOPENED PACK FROM LOT U8737. A FUNCTIONAL TEST WAS PERFORMED AND PERFORMED AS REQUIRED. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 2. SEE 1920664-2013-00083.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTERS FAILED TO CUT PROPERLY. THE CUTTERS PASSED THE VITRECTOMY TEST, AND WERE ASPIRATING PROPERLY. THE DOCTOR OBSERVED UNDER THE MICROSCOPE AND CUTTER WAS NOT OPENING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165649 STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5623 U8737

    Patients

    Seq Age Sex Outcome Treatment
    1