BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESECTOSCOPE

    MDR report key: 747132 · Received November 2, 2005

    Report

    Report Number
    MW1036550
    Event Type
    Other
    Date Received
    November 2, 2005
    Date of Event
    October 19, 2005
    Report Date
    October 21, 2005
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "IN THE PROCESS OF A ROUTINE TRANSURETHRAL RESECTION OF A BLADDER TUMOR THE SCRUB TECH NOTICED SMOKE BEING GENERATED FROM AROUND THE AREA OF THE RESECTOSCOPE HANDPIECE. ON INSPECTION OF THE HANDPIECE, A BLACK DISCOLORATION WAS NOTICED AROUND THE AREA OF THE RESECTOSCOPE THAT CONNECTS TO THE BOVIE CORD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESECTOSCOPE STERN MCCARTHY FED OLYMPUS AMERICA, INC. A22063A *
    2 RESECTOSCOPE BOBLE CORD FJL OLYMPUS AMERICA, INC. A00012A *
    3 RESECTOSCOPE ELECTRODE LOOP 24 FRENCH FJL OLYMPUS AMERICA, INC. A22201CAJ *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other