BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITRECTOMY CUTTER

    MDR report key: 3437365 · Received October 3, 2013

    Report

    Report Number
    1920664-2013-00249
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 13, 2013
    Manufacturer
    BAUSCH + LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 3 SEE 1920664-2013-00250 AND 1920664-2013-00251.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER WOULD NOT CUT ALTHOUGH ASPIRATION WAS PRESENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501297 STELLARIS 25G VITRECTOMY CUTTER HQC BAUSCH + LOMB, INC. BL5625 V0010

    Patients

    Seq Age Sex Outcome Treatment
    1