BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOCLAVABLE URETEROSCOPE

    MDR report key: 1971796 · Received January 13, 2011

    Report

    Report Number
    1519132-2011-00004
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 13, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K052044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INSTRUMENT FINDS THE TUBS IS BENT BEYOND DESIGN SPECIFICATIONS LEAVING A SEVERE BEND IN TUBE WHICH HAS CAUSED DAMAGE TO THE LIGHT FIBERS REDUCING LIGHT OUTPUT BY 42%. FURTHER INSPECTION OF THE DISTAL TIP OF INSTRUMENT SHOWS ABRASION MARKS THAT HAS ONLY SLIGHTLY ALTERED ITS EDGE. INSTRUMENT HAS BEEN SUBJECTED ABNORMAL USE OR CONDITIONS CAUSING DAMAGE TO THE TELESCOPE TUBE AND MINOR WEAR TO DISTAL TIP. THE BENT TUBE IS UNACCEPTABLE FOR RETURN TO THE FIELD, THE WEAR CONDITIONS ON THE TIP IS NOTED BUT MEETS ACCEPTANCE CRITERIA FOR THE INSTRUMENT. THE STATEMENT BY THE CUSTOMER THAT THE LENS IS SHARP CANNOT BE CONFIRMED. THE INSTRUMENT CANNOT BE REPAIRED DUE TO THE SEVERE BEND AND BROKEN FIBERS AND WILL NOT BE RETURNED TO SERVICE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE SURGEON INDICATED THAT THE END OF THE URETEROSCOPE LENS WAS SHARP AND CUTTING INTO THE URETER. SEVERAL ATTEMPTS WERE MADE TO GET MORE INFO FROM THE CUSTOMER WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCLAVABLE URETEROSCOPE URETEROSCOPE FGB GYRUS ACMI, INC. RMR-6A

    Patients

    Seq Age Sex Outcome Treatment
    1