BEUDAMED
    FDA Adverse Event Summary report: N

    SLIM LINE EZ SURGICAL FIBER

    MDR report key: 2258299 · Received September 21, 2011

    Report

    Report Number
    3004135191-2011-00049
    Date Received
    September 21, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 21, 2011
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K990947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED BY LUMENIS. DURING THE INVESTIGATION, LUMENIS CONTACTED THE INITIAL REPORTER. LUMENIS WAS INFORMED BY INITIAL REPORTER THAT NO PATIENT ADVERSE OUTCOME OCCURRED AS A RESULT OF THE EVENT REPORTED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE SUBJECT DEVICE FROM THE USER FACILITY FOR EXAMINATION, HOWEVER THE DEVICE WAS NOT RETURNED. THEREFORE, A DETERMINATION OF ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE BE RETURNED FOR EXAMINATION, A FOLLOW-UP MDR WILL BE FILED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON A VOLUNTARY MEDWATCH (B)(4), FILED BY A USER FACILITY,THAT A LUMENIS SLIMLINE FIBER DID NOT FUNCTION AS EXPECTED DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIM LINE EZ SURGICAL FIBER LASER FIBER DELIVERY DEVICE ACCESSORY GEX LUMENIS, LTD. EZ 42050311

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other