BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTION SHEATH

    MDR report key: 3812483 · Received May 5, 2014

    Report

    Report Number
    2951238-2014-00195
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORTED PHENOMENON. EVALUATION FOUND A PORTION OF THE WHITE CERAMIC BEAK BROKEN OFF FROM THE DISTAL END. THE BROKEN PIECES OF THE WHITE BEAK WERE NOT RECOVERED. THERE ARE SCRATCHES AROUND THE BROKEN WHITE BEAK, WHICH IS EVIDENCE OF IMPACT DAMAGE THAT CAUSE THE BREAKAGE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT NEAR THE COMPLETION OF A TRANSURETHRAL RESECTION BLADDER CLOT RESECTION, THE TIP OF THE RESECTION SHEATH BROKE OFF INSIDE THE PATIENT. TWO FOREIGN BODIES WERE IDENTIFIED IN THE BLADDER MEASURING 5X4 MM AND 2X2 MM RESPECTIVELY. THE DOCTOR TRIED TO RETRIEVE THE LARGER OF THE TWO FOREIGN BODIES WITH A GRASPER UNDER DIRECT VISUALIZATION. HOWEVER, IT WOULD NOT PASS THROUGH THE RESECTOSCOPE SHEATH. UNDER FLUOROSCOPIC GUIDANCE, THE FOREIGN BODIES WERE IDENTIFIED AS BROKEN FRAGMENTS FROM THE TIP END OF THE RESECTOSCOPE SHEATH. THE LARGER FOREIGN BODY COULD NOT BE REMOVED AND REMAINED LODGED IN THE RIGHT LATERAL WALL OF THE BULBAR URETHRA. A PLANNED REMOVAL AND POSSIBLE REPAIR OF THE URETHRA WILL OCCUR FOLLOWING AND ALLOTTED PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267916 RESECTION SHEATH RESECTION SHEATH FJL GYRUS ACMI INC. A22042A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention