BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 5653435 · Received May 13, 2016

    Report

    Report Number
    1820334-2016-00374
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K): K151051. EVENT EVALUATION: THIS HISTORICAL COMPLAINT IS BEING FILED UNDER 21 CFR PART 803 AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES. A REVIEW OF DOCUMENTATION AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE IN THIS CASE WAS RETURNED TO ASSIST WITH THIS INVESTIGATION. EXAMINATION OF THE DEVICE OBSERVED: ONE SPECIMEN CUP CONTAINING A SEPARATED STENT WAS RECEIVED. THE STENT WAS RETURNED IN TWO SEGMENTS NOTING THE MAJORITY OF THE STENT WAS COVERED WITH A LIGHT LAYER OF ENCRUSTATION. THE FIRST SEGMENT MEASURED 1.2CM AND THE SEVERED END WAS SEVERELY MELTED AND FUSED WITH THE THRU HOLE COMPLETELY CLOSED ON THE END OF THE SMALL SEGMENT. THE COILED END ON THE STENT WAS SEVERELY MELTED FUSED CLOSED, THE CUSTOMER INDICATED A LASER WAS USED ON THE STENT DURING REMOVAL. THERE WAS NO KNOT OBSERVED IN THE STENT, HOWEVER THE ENTIRE STENT WAS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THIS PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THE APPROPRIATE MANUFACTURING CONTROLS ARE IN PLACE ASSURING FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPMENT. THE DEVICE LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. A REVIEW OF THE INSTRUCTIONS FOR USE INDICATED INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. PERIODIC EVALUATION VIA CYSTOSCOPE, RADIOGRAPHIC, OR ULTRASONIC MEANS IS SUGGESTED. A RARE COMPLICATION OF INDWELLING URETERAL STENTS IS KNOT FORMATION WITHIN THE BODY OR COILED PORTION OF THE URETERAL STENT. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED IN THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR STENT REMOVAL AND TO LASER A STONE. THE DOCTOR FOUND THE STENT TO BE KNOTTED. THE DOCTOR USED THE LASER ON THE STONE AND THE STENT, THEN REMOVED BOTH. THE DOCTOR MENTIONED THAT HE HAD EXPERIENCED THIS ON TWO OTHER OCCASIONS BUT DID NOT REPORT THEM. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309383 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention