BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUOTOME 550

    MDR report key: 819033 · Received February 13, 2007

    Report

    Report Number
    2914019-2007-00003
    Event Type
    Other
    Date Received
    February 13, 2007
    Date of Event
    January 9, 2007
    Report Date
    February 13, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    LNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE ASSOCIATED POWERSUITE 100 WATT DEVICE AND THE CUSTOMER ENGINEER DID NOT FIND ANY PROBLEMS WITH THIS DEVICE. LUMENIS HAS NOT BEEN INFORMED AS OF 2/13/2007 WHETHER OR NOT THE ENDUSER EXPECTED TO RETURN THE FIBER TO LUMENIS FOR EVALUATION. IF DEVICE EVALUATION RESULTS BECOME AVAILABLE IN THE FUTURE, LUMENIS WILL FILE A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    DURING A UROLOGY PROCEDURE, A DUOTOME FIBER BROKE AND BURNED THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUOTOME 550 SURGICAL FIBER LNK LUMENIS LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED