BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6720654 · Received July 18, 2017

    Report

    Report Number
    1820334-2017-01710
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 20, 2017
    Report Date
    December 18, 2017
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DOCUMENTATION, AND QUALITY CONTROL DATA WAS PERFORMED. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS ALSO CONDUCTED DURING THE INVESTIGATION. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE UNIDEX HANDLE (UDH) IN THE CLOSED POSITION AND THE BASKET FORMATION WAS PARTIALLY OPEN. A FUNCTIONAL TEST WAS PERFORMED AND THE UDH HANDLE ACTUATED THE BASKET FORMATION TO THE OPEN POSITION. WHEN ACTUATED TO THE CLOSED POSITION, THE BASKET FORMATION APPEARED TO GAP. UNDER MAGNIFICATION, ONE OF THE BASKET WIRES APPEAR TO HAVE BEEN ¿CAUGHT¿ ON SOMETHING AND PULLED IT OUT OF ALIGNMENT WITH THE OTHER BASKET WIRES CREATING THE GAP THAT WAS NOTED. 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. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS COMPLAINT DEVICE LOT NUMBER 7729837. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED. 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 THAT THE PHYSICIAN WAS PERFORMING AN INTENDED URETEROSCOPY PROCEDURE ON A PATIENT BY USING THE NGAGE NITINOL STONE EXTRACTOR. THE PHYSICIAN NOTICED THE TIP OF THE DEVICE WAS NOT IN THE ORIGINAL SHAPE AND WAS UNABLE TO CLOSE ALL THE WAY THUS IT DID NOT FIT INTO THE CYSTOSCOPE. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING ANOTHER NGAGE NITINOL STONE EXTRACTOR DEVICE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503911 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 00827002482944

    Patients

    Seq Age Sex Outcome Treatment
    1