BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 3162478 · Received June 6, 2013

    Report

    Report Number
    1920664-2013-00135
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. ONE 23GA CUTTER WAS RETURNED IN AN UNK POUCH. THE ORIGINAL PACKAGING WAS NOT RETURNED. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS SLIGHTLY BENT APPROXIMATELY 5" OR LESS. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. THE BACK CAP WAS OFF CENTER OF THE VENT HOLE IN THE SIDE OF THE CUTTER BODY BY APPROXIMATELY 45 DEGREES. THE DRIVE CONNECTION DAMPENER AND BARB CONNECTOR (AIR LINE) WAS NOT FULLY SEATED INTO THE BACK CAP AND WAS LOOSE. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER HAS AN AIR LEAK AT THE BACK CAP AIR LINE. THE INNER NEEDLE WILL NOT ACTUATE OR MOVE DUE TO THE LOOSE AIR LINE CONNECTION. THE CUTTER DOES NOT CUT. HOWEVER, THE CUTTER DOES ASPIRATE. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN KOREA REPORTED THE VITRECTOMY CUTTER PASSED PRE-OPERATIVE TESTING, BUT FAILED TO CUT THROUGH THE VITREOUS DURING THE SURGICAL PROCEDURE ALTHOUGH ASPIRATION CONTINUED. THE CUTTER WAS TESTED AT VARIOUS SPEEDS AND FAILED TO CUT PROPERLY AT 5000 CPM. THERE WAS NO PT IMPACT OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251650 STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5623 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1