BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ BARRETT NUCLEUS MANIPULATOR

    MDR report key: 3193123 · Received June 25, 2013

    Report

    Report Number
    1920664-2013-00160
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    KGE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADD'L INFO IS REC'D.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE TIP BROKE OFF OF THE INSTRUMENT DURING A SURGICAL PROCEDURE. THE SURGERY WAS DELAYED; HOWEVER IS IT UNK HOW LONG. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287748 STORZ BARRETT NUCLEUS MANIPULATOR HANDHELD SURGICAL INSTRUMENT KGE BAUSCH & LOMB, INC. E4933 NA

    Patients

    Seq Age Sex Outcome Treatment
    1