BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 20G VIT CUTTER 6/BX

    MDR report key: 3040445 · Received April 3, 2013

    Report

    Report Number
    1920664-2013-00045
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 6, 2013
    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 DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD THE DEVICE BECOME AVAILABLE FOR INVESTIGATION. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING SURGERY THE VITRECTOMY CUTTER AND ASPIRATION WAS WORKING, BUT THE CUTTER WAS NOT CUTTING THROUGH PROPERLY. THEY HAD NO PROBLEM WHEN TESTING FOR USE PRIOR TO THE SURGERY STARTING. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136452 STELLARIS 20G VIT CUTTER 6/BX HQC BAUSCH & LOMB, INC. BL5620 U8845

    Patients

    Seq Age Sex Outcome Treatment
    1