BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITERECTOMY CUTTER

    MDR report key: 4924386 · Received July 16, 2015

    Report

    Report Number
    1920664-2015-00104
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER DID NOT CUT AT 5000CPM. THE DOCTOR DECREASED THE CUT RATE TO 2500CPM AND THE SURGERY WAS COMPLETED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463676 STELLARIS 25G VITERECTOMY CUTTER HQC BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1