BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 1292851 · Received January 16, 2009

    Report

    Report Number
    1825146-2009-00001
    Event Type
    Injury
    Date Received
    January 16, 2009
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    FFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED STONE EXTRACTOR WAS RECEIVED IN THE OPEN POSITION AS WELL AS A SEPARATED WIRE MAKING UP HALF OF THE BASKET. THE SEPARATED BASKET SEGMENT WAS NOTED TO BE COMPRISED OF THE NON-CONTINUOUS SHAFT WIRES AND HAD DRIED TISSUE COVERING THE LOOP AREA. UPON EXAMINING THE SEPARATED BASKET WIRE SEGMENT, IT WAS OBSERVED THAT ONE END OF THE WIRE WAS PULLED OUT OF THE CANNULA AND THE OPPOSITE END WAS NOTED TO HAVE SEPARATED JUST ABOVE THE CANNULA. UPON CLOSELY EXAMINING THE POINT OF SEPARATION, THE WIRE WAS NOTED TO HAVE AN ELONGATED/CONE APPEARANCE. WHEN VIEWING THE DISTAL CANNULA, STILL PRESENT ON THE MAIN BODY OF THE STONE EXTRACTOR, IT WAS NOTED TO HAVE BEEN MOVED FROM THE ORIGINAL LOCATION TO THE TIP/LOOP AREA OF THE BASKET. THREE OF THE FOUR WIRES WERE OBSERVED INSIDE THE CANNULA, NOTING ADHESIVE INSIDE THE CANNULA AS WELL AS ON THE THREE REMAINING WIRES; THE COMPLETE STONE EXTRACTOR WAS RETURNED FOR EVAL. MOST LIKELY, EXCESSIVE FORCE PULLING ON THE BASKET HAS CAUSED ONE END OF THE WIRE TO SEPARATE AND THE OPPOSITE END OF THE WIRE TO DISLODGE FROM THE CANNULA DUE TO INADEQUATE ADHESIVE APPLIED DURING THE MFG PROCESS. THE PROPER DEPT HAS BEEN NOTIFIED OF THIS OCCURRENCE. EACH STONE EXTRACTOR IS 100% INSPECTED PRIOR TO PACKAGING TO ENSURE INTEGRITY.

    Description of Event or Problem · 1

    THIS EXTRACTOR BROKE AS THE BASKET WAS BEING PULLED BACK THROUGH THE SHEATH. IT DID HAVE A STONE IN THE BASKET AT THE TIME. THE ENTIRE LOOP BROKE OFF AND WE SPENT HOURS SEARCHING FOR IT IN THE BODY. WHEN WE DID, WE INCLUDED THE BROKEN PIECE IN THE PACKAGING. I MADE SURE TO ASK THE PHYSICIAN IF THERE WAS RESISTANCE ENTERING THE SHEATH OR IF HE FELT IT BREAK? I ALSO ASKED HIM IF THERE WERE EDGES OF THE STONE OUTSIDE THE SHEATH THAT COULD HAVE CAUSED THE BASKET TO BREAK UPON ENTERING? HIS REPLY TO ALL OF THIS WAS NO. HE WAS REALLY UPSET. HE HAD AN ENDOUROLOGY FELLOWSHIP AFTER RESIDENCY AND SAID HE HAS NEVER SEEN A BASKET BREAK THIS WAY. HE SAID THERE WAS NO FEELING OF BEING HUNG UP. THE EXTRACTOR ADVANCED SMOOTHLY INTO THE SHEATH WHEN HE REALIZED IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCIRCLE TIPLESS STONE EXTRACTOR FFD EVACUATOR, BLADDER, MANUALLY OPERATED FFD COOK UROLOGICAL INC U1788470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention