BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL FIBER

    MDR report key: 1576526 · Received January 11, 2010

    Report

    Report Number
    2914019-2010-00001
    Event Type
    Death
    Date Received
    January 11, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 7, 2010
    Manufacturer
    LUMENIS LTD. YOKNEAM
    Product Code
    GEX
    PMA / PMN Number
    K011703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RELATED DEVICE MALFUNCTION WAS REPORTED BY THE USER FACILITY. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE SUBJECT DEVICE FROM THE USER FACILITY; HOWEVER, IT WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DIED FOLLOWING A HOLAP PROCEDURE USING A LUMENIS PRODUCT. IT WAS FURTHER REPORTED BY THE TREATING PHYSICIAN AT THE USER FACILITY THAT THE PT'S DEATH WAS IN NO WAY RELATED TO THE SUBJECT LUMENIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FIBER HO:YAG SURGICAL LASER DELIVERY DEVICE:DUO TOME GEX LUMENIS LTD. YOKNEAM 840-846 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death