BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 3379424 · Received September 3, 2013

    Report

    Report Number
    1920664-2013-00224
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    August 7, 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

    THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2. SEE 192664-2013-00223.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED VITRECTOMY CUTTER WAS OPENED AND WOULD NOT CUT UNDER 5000 CPM. THE CUTTER STARTED TO WORK WHEN REDUCED TO 1000 CPM THEN STOPPED AFTER 20 SECONDS. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436374 STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5623 U7481

    Patients

    Seq Age Sex Outcome Treatment
    1