BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCOMPASS NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 2230623 · Received August 11, 2011

    Report

    Report Number
    1825146-2011-00032
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 10, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL AT THIS TIME, UPON RECEIPT OF THE DEVICE A F/U REPORT WILL BE SENT. IN VIEWING THE INITIAL INFO RECEIVED, DURING REMOVAL OF THE LARGE (9 MM) STONE, A LACERATION IN THE URETER OCCURRED NOTING THE STONE TO EXIT THE URETER AND WAS NOTED TO BE LOCATED IN THE RETROPERITONEAL SPACE. DURING OPEN SURGERY THE STONE WAS RETRIEVED ALONG WITH THE TREATMENT OF THE URETER WITH URETERO-URETEROSTOMY AND PLACEMENT OF A CATHETER. THE PT DID EXPERIENCE PAIN AND EXTENDED DURATION OF THE URETERAL CATHETER AND FOLEY CATHETER. ADD'L INFO IS BEING REQUESTED.

    Description of Event or Problem · 1

    FLEXIBLE URETEROSCOPY - PYELOSCOPY WAS PERFORMED AND THE STONE WAS LOCATED (DIAMETER ABOUT 9 MM). THE STONE WAS CAPTURED. DURING ITS EXTRACTION, ALTHOUGH THE FORCE APPLIED WAS MILD, VISUAL CONTACT WITH THE CAPTURED STONE WAS LOST. THE EXTRACTOR WAS THEN MOVED OUT AND ITS WIRES WERE FOUND TO BE SNAPPED IN A CONCAVED SHAPE. THE FLEXIBLE URETEROSCOPE WAS REMOVED AND RIGID URETEROSCOPY WAS PERFORMED IN ORDER TO EVALUATE THE SITUATION; THE STONE WAS NOT FOUND IN THE URETER WHILE THE MIDDLE THIRD OF THE URETER ITSELF WAS DIAGNOSED WITH A LACERATION ABOUT 2 CM IN LENGTH. OPEN SURGERY WAS PERFORMED. THE STONE WAS RETRIEVED FROM THE RETROPERITONEAL SPACE. THE URETERAL INJURY WAS RE-EVALUATED AND TREATED WITH URETERO-URETEROSTOMY. FINALLY, AN URETERAL CATHETER WAS PLACED. ADVERSE EFFECTS ON THE PT REPORTED: PAIN RELATED TO THE LAPAROTOMY, LATE REMOVAL OF THE URETERAL CATHETER, LATE REMOVAL OF THE FOLEY CATHETER (EFFECTS UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCOMPASS NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK UROLOGICAL, INC. NA U1998973

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention