BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23G VITRECTOMY CUTTER

    MDR report key: 4102346 · Received August 27, 2014

    Report

    Report Number
    1920664-2014-00160
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 31, 2014
    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 WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER WAS NOT OPERABLE AT THE CUTTING SPEED OF 5000 CPM. THEY CHECKED THE OPERATION OF THE CUTTER STARTING WITH A SPEED OF 2000-3000 CPM AND THEN GEARED UP TO 5000 CPM, WHERE THE CUTTER DID NOT FUNCTION PROPERLY. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522808 STELLARIS 23G VITRECTOMY CUTTER STELLARIS 23G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. V2867

    Patients

    Seq Age Sex Outcome Treatment
    1