BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 1063683 · Received June 19, 2008

    Report

    Report Number
    1920664-2008-00646
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    MLZ
    PMA / PMN Number
    K980488
    Removal / Correction Number
    Z-765/766-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THIS DEVICE WAS REPROCESSED AND REUSED.

    Description of Event or Problem · 1

    THE TIP OF THE VITRECTOMY CUTTER BROKE OFF INTO THE PATIENT'S EYE DURING SURGERY CAUSING THE SURGEON TO STOP. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH SPEED VITRECTOMY CUTTER OPHTHALMIC MICROSURGICAL ACCESSORY PACK MLZ BAUSCH & LOMB, INC. NA T8718

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK