BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD

    MDR report key: 7031775 · Received November 14, 2017

    Report

    Report Number
    2951238-2017-00723
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 14, 2017
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    FBO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, THE INSTRUCTION MANUAL WARNS USERS "DO NOT USE AN INSTRUMENT THAT FAILS TO MEET THE CRITERIA STATED IN THE LABELING OR THAT HAS BEEN DAMAGED. DAMAGE MAY RESULT IN THE LOSS OF THE ENTIRE CERAMIC TIP OR FRAGMENTS OF THE CERAMIC TIP. IF THERE IS EVIDENCE OF CHARRING, BURN SPOTS, CHIPS OR CRACKS IN THE CERAMIC TIP OR SURROUNDING AREA, DO NOT USE. "

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE PLASTIC TIP OF THE OUTER SHEATH BROKE OFF INTO THREE PIECES AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE SURGEON RETRIEVED ALL THREE PIECES OF THE PLASTIC TIP FROM THE PATIENT. THE ADJACENT AREAS WERE INSPECTED FOR TRAUMA AND NONE WAS NOTED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810099 USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD USA ELITE SYSTEM ROTATING CF OUTER SHEATH FBO GYRUS ACMI, INC EROS-CF25 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1