BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 3963732 · Received June 19, 2014

    Report

    Report Number
    1920664-2014-00090
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 23, 2014
    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

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER WAS INOPERABLE WHEN SET AT THE CUTTING SPEED OF 5000 CPM. STARTING AT A LOWER SPEED OF 2000-3000 CPM THEY CHECKED THE OPERATION OF THE CUTTER AND THEN INCREASED THE SPEED TO 5000 CPM, WHERE THE CUTTER WOULD NOT WORK PROPERLY. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359405 STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. V1098

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR