BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 3243236 · Received July 19, 2013

    Report

    Report Number
    1920664-2013-00181
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 1920664-2013-00180.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE SURGEON FOUND THE CUTTER WAS CUTTING EFFICIENTLY AT 2500CPM BUT WAS NOT CUTTING EFFICIENTLY AT 4000CPM. NO PATIENT INJURY AND SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337952 STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5623 U8345

    Patients

    Seq Age Sex Outcome Treatment
    1