BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 1227043 · Received November 11, 2008

    Report

    Report Number
    MW5008962
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY WHILE PHYSICIAN WAS LASERING THE PROSTATE, THE TIP OF THE LASER FILTER FELL OFF INTO THE FIELD. IT WAS RETRIEVED IN ITS ENTIRELY USING A GRASPER. A SECOND FILTER WAS OPENED AND THE CASE CONTINUED. PHYSICIAN: DR. WALDMAN ADMITTING DIAGNOSIS: BENIGN PROTSTATIC HYPERTROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORPORATION DUO TOME SIDE LITE LNK BOSTON SCIENTIFIC CORPORATION 550 72000308

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability