BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIM LINE EZ SURGICAL FIBER

    MDR report key: 2535473 · Received April 13, 2012

    Report

    Report Number
    3004135191-2012-00021
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    March 14, 2012
    Report Date
    April 13, 2012
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K990947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED SUBJECT DEVICE BY LUMENIS TECHNICAL SPECIALIST CONFIRMED THE ROOT CAUSE FOR THE REPORTED EVENT TO BE IMPROPER HANDLING OF THE FIBER WITHOUT PATIENT CONTACT EITHER DURING THE CLINICAL PROCEDURE OR UNPACKING/PREPARATION IN CONTRADICTION TO THE DFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LUMENIS SLIMLINE 550EZ FIBER BROKE DURING USE CAUSING A BURN TO A NURSE'S UNIFORM. IT WAS FURTHER REPORTED THAT THE BREAK CAUSED NO HARM TO THE NURSE AND ONLY A SMALL BURN TO THE GOWN. 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 40110211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other