BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6804626 · Received August 18, 2017

    Report

    Report Number
    1820334-2017-02683
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Report Date
    November 27, 2017
    Manufacturer
    COOK INC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: INITIAL REPORTER NAME AND OCCUPATION ADDED. TYPE OF PROCEDURE PERFORMED: URETEROSCOPY. THE DEVICE DID NOT COME PATIENT'S CONTACT AS IT WAS TESTED PRIOR TO ACTUAL USE. (B)(4). INVESTIGATION ¿ EVALUATION: THE NGAGE NITINOL STONE EXTRACTOR WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY FOR THE PRODUCT AND LOT NUMBER COMBINATION COULD NOT BE COMPLETED WITHOUT THE LOT NUMBER. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE AREA REPRESENTATIVE THAT TWO (2) NGAGE NITINOL STONE EXTRACTORS DID NOT FUNCTION AT ALL WHEN THEY WERE REMOVED FROM THE PACKAGE. AS REPORTED, THE PATIENT WAS NOT AFFECTED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS DEVICE ISSUE. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT FILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583046 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1