BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITRECTOMY CUTTER

    MDR report key: 3080973 · Received April 24, 2013

    Report

    Report Number
    1920664-2013-00106
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 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 DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2. SEE 1920664-2013-00094.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE CUTTER DID NOT WORK. THEY OPENED ANOTHER CUTTER AND IT DID NOT WORK AT 5000CPM. NO PATIENT INJURY REPORTED. THE CUTTER WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176338 STELLARIS 25G VITRECTOMY CUTTER HQC BAUSCH & LOMB, INC. BL5625 U9464

    Patients

    Seq Age Sex Outcome Treatment
    1