BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-CATCH NT

    MDR report key: 4180762 · Received October 15, 2014

    Report

    Report Number
    2951238-2014-00461
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE BASKET WAS DETACHED. BOTH VISUAL AND DIMENSIONAL EXAMINATIONS INDICATE THAT THE DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS. FURTHER VISUAL INSPECTION SHOWED BUCKLING OF THE SHEATH IN THREE LOCATIONS AT THE MID-SECTION BETWEEN 45-62CM FROM THE DISTAL END. THIS DAMAGE IS CHARACTERISTIC OF EXCESSIVE FORCE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY DISCREPANCIES DURING THE MANUFACTURING OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL URETEROSCOPY IN THE LEFT URETER, THE SURGEON WAS HAVING DIFFICULTY PASSING THE WIRE THROUGH AN OBSTRUCTION OF STONES AND TISSUE. AFTER BREAKING UP SOME OF THE OBSTRUCTION HE USED THE DEVICE TO GRASP A LARGE STONE THAT WAS 3/4 OF THE WAY UP THE URETER. WHEN PULLING THE STONE DOWN PAST THE OBSTRUCTION THE BASKET BROKE OFF WITH THE STONE STILL INSIDE. THE PHYSICIAN THEN USED ANOTHER DEVICE TO RETRIEVE THE BASKET AND STONE. THE INTENDED PROCEDURE WA NOT COMPLETED. THE PHYSICIAN HA COMPLETED THE LEFT SIDE OF THE URETER HOWEVER, THE PROCEDURE WAS ABORTED AND THE RIGHT SIDE OF THE URETER WA NOT COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653000 ULTRA-CATCH NT STONE RETRIEVAL BASKET FFL GYRUS ACMI, INC. NT4W18115 MK886124

    Patients

    Seq Age Sex Outcome Treatment
    1