BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL FIBER

    MDR report key: 705983 · Received April 28, 2006

    Report

    Report Number
    2914019-2006-00032
    Event Type
    Other
    Date Received
    April 28, 2006
    Date of Event
    March 29, 2006
    Report Date
    April 28, 2006
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO OR THREE MILLIMETERS BROKE OFF THE TIP OF A SLIMLINE 365 FIBER FROM LOT 3175/0705 DURING A PROCEDURE IN 2006 AT THE HOSP. THE FIBER FRAGMENT, WHICH IS BIOCOMPATIBLE, REMAINED IN THE KIDNEY LUMENIS REPORTED THE INCIDENT TO LUMENIS REGULATORY IN 2006. LUMENIS ANTICIPATED A VISIT TO THE HOSP TO OBTAIN ADDITIONAL INCIDENT AND PT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FIBER LASER FIBER DELIVERY DEVICE GEX LUMENIS SLIMLINE 365 3175/07/05

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention