BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 1424261 · Received March 26, 2009

    Report

    Report Number
    1920664-2009-00078
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    February 27, 2009
    Report Date
    February 27, 2009
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MLZ
    PMA / PMN Number
    K980488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS CUTTER FAILED DURING A VITRECTOMY PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY, AND IT IS LIKELY ANOTHER CUTTER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH SPEED VITRECTOMY CUTTER OPHTHALMIC MICROSURGICAL ACCESSORY PACK MLZ BAUSCH & LOMB NA U0198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK