BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE SYSTEM M3 AUTOCL. FOROBLIQUE SCOPE

    MDR report key: 1565285 · Received December 17, 2009

    Report

    Report Number
    1519132-2009-00033
    Event Type
    Other
    Date Received
    December 17, 2009
    Date of Event
    November 10, 2009
    Report Date
    December 17, 2009
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBP
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SCOPE REVEALED SEVERE BURN MARKS AND EXCESSIVE HEAT DISCOLORATION AT THE DISTAL TIP. THE STAINLESS STEEL OUTER TUBE HAS BEEN SEVERELY MELTED IN TWO DIFFERENT LOCATIONS AND THE LIGHT FIBERS HAVE BEEN DAMAGED AT THOSE SAME LOCATIONS AND THE LIGHT FIBERS HAVE BEEN DAMAGED AT THOSE SAME LOCATIONS. IT IS ALSO NOTED THAT MOISTURE CAN BE SEEN IN THE LENS TRAIN USING A 10X EYE LOUPE. THE DISTAL WINDOW IS CHIPPED AT 12 O'CLOCK POSITION WHEN VIEWING FROM DISTAL END AND THE LIGHT POST UP. THE IMAGE IS NOTED AS CLOUDY DUE TO INTERNAL DAMAGE TO THE TELESCOPE, LIKELY DUE TO OVERHEATING. LIGHT OUTPUT IS AT 8.11%, WELL BELOW THE REQUIRED 22%. DAMAGE APPEARS TO BE USER ERROR. REPAIR IS REQUIRED.

    Description of Event or Problem · 1

    THE SURGEON WAS USING AN M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE DURING A TURF PROCEDURE, HE COMPLAINED THAT THERE WAS NO PROPER VISUALIZATION. HE WAS NOT USING A CAMERA. THE SURGEON ABORTED THE CASE MID-WAY THROUGH THE PROCEDURE. HE WENT TO PLACE THE CATHETER AND REALIZED THAT IT WAS NOT SEATED PROPERLY. WHEN HE TOOK OFF THE DRAPES, HE NOTICED THAT THE PT'S ABDOMEN WAS DISTORTED. THE SURGEON OPENED THE PT AND FOUND THAT THE BLADDER HAD BEEN PERFORATED. THE PT SPENT SOME TIME IN THE ICU, BUT HAS SINCE BEEN SENT HOME. A LOOP AND A DAC CORD WERE ALSO USED IN THE PROCEDURE, BUT WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM M3 AUTOCL. FOROBLIQUE SCOPE AUTOCLAVABLE FOROBLIQUE TELESCOPE FBP GYRUS ACMI, INC. M3-30A

    Patients

    Seq Age Sex Outcome Treatment
    1