BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 4223761 · Received October 30, 2014

    Report

    Report Number
    1820334-2014-00556
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    June 27, 2014
    Report Date
    October 6, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    UPON VISITATION TO THE FACILITY, THE NURSE ADVISED THE REP THAT DURING A PCNL PROCEDURE, DIFFICULTY WAS EXPERIENCED WHEN A PERC NCIRCLE BASKET BROKE DURING SURGERY. IT WAS NECESSARY TO USE FORCEPS TO REMOVE THE DEVICE FROM THE BODY OF THE PATIENT. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694653 PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK, INC. NA U2481169

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention