BEUDAMED
    FDA Adverse Event Other Summary report: N

    MR-6A

    MDR report key: 972162 · Received December 19, 2007

    Report

    Report Number
    1519132-2007-00011
    Event Type
    Other
    Date Received
    December 19, 2007
    Date of Event
    November 26, 2007
    Report Date
    December 19, 2007
    Manufacturer
    GYRUS ACMI, INC. - NORWALK
    Product Code
    FGB
    PMA / PMN Number
    K052044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE URETEROSCOPE MR-6A, THE URETER WAS PERFORATED. THE SURGEON STATED THAT THE TIP WAS TOO SHARP. WHEN THE PT WAS IN RECOVERY, THE CATHETER WAS REMOVED. THE PT WAS IN PAIN AND REQUIRED LONGER HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR-6A URETEROSCOPE, 33CM FGB GYRUS ACMI, INC. - NORWALK MR-6A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization