BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOURETHROSCOPE SHEATHS 23FR

    MDR report key: 5021497 · Received August 21, 2015

    Report

    Report Number
    2951238-2015-00395
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    GYRUS ACMI INC,
    Product Code
    FBO
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT CONFIRM THE REPORTED EVENT. A VISUAL INSPECTION OF THE DEVICE FOUND NO SCRAPES, DENTS OR OTHER DAMAGE THAT SHOWS METAL OR PIECES OF THE DEVICE FELL OFF THE UNIT. THE EXACT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. CROSS REFERENCE:2951238-2015-00399, 2951238-2015-00400.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, METAL FLAKES FROM SEVERAL DIFFERENT COMPONENTS ON THE DEVICE WERE FALLING OFF INTO THE PATIENT'S BLADDER. THE SURGEON USED A GRASPER AND SUCCESSFULLY RETRIEVED ALL THE DEVICE FRAGMENTS. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND. THIS IS ONE OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556482 CYSTOURETHROSCOPE SHEATHS 23FR CYSTOURETHROSCOPE SHEATH FBO GYRUS ACMI INC, E123-S MF

    Patients

    Seq Age Sex Outcome Treatment
    1