BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 2EGA VITRECTOMY CUTTER

    MDR report key: 3282838 · Received August 1, 2013

    Report

    Report Number
    1920664-2013-00187
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 3 OF 3. SEE 1920664-2013-00185 AND 1920664-2013-00186.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING SURGERY THE CUTTER WOULD NOT PERFORM. THEY OPENED ADDITIONAL CUTTERS TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361274 STELLARIS 2EGA VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5623 U8586

    Patients

    Seq Age Sex Outcome Treatment
    1