BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 1362056 · Received April 14, 2009

    Report

    Report Number
    MW5010730
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 6, 2009
    Product Code
    LNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKEN LASER DELIVERS DEVICE CAUSED BURN TO HAND OF OPERATOR DURING CYSTO ELECTRO VAPORIZATION OF PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. DUO TOME SIDE LITE 550 LNK DUO TOME SIDE LITE 70960208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other