BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6730701 · Received July 20, 2017

    Report

    Report Number
    1820334-2017-01718
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    April 7, 2017
    Report Date
    January 30, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482951
    Removal / Correction Number
    1820334-2017-01718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED DURING THE INVESTIGATION. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DOCUMENTATION, QUALITY CONTROL DATA AND SPECIFICATIONS WAS ALSO CONDUCTED. NO ISSUES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED COMPLAINT. ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE UNIDEX (UDH) HANDLE AND THE BASKET FORMATION IN THE CLOSED POSITION. A VISUAL EXAMINATION NOTED A KINK AT THE BASE OF THE SUPPORT SHEATH. ONE OF THE BASKET WIRES WERE OBSERVED TO BE SEPARATED AND PART OF THE WIRE APPEARS TO BE MISSING. A FUNCTIONAL TEST WAS PERFORMED AND THE UDH HANDLE DOES ACTUATE THE BASKET FORMATION. BASED ON THE INVESTIGATION EVALUATION, 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 FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE MODE OF DEVICE BEING CRACKED/BROKEN. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 6971053. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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

    THE 9.5 FR SHEATH AND FLEXIBLE URETEROSCOPE. (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

    DURING A KIDNEY STONE EXTRACTION PROCEDURE THE BASKET "BROKE OR CRACKED". NO PIECES OF THE BASKET SEPARATED FROM THE DEVICE. THE PRODUCT WAS REPLACED AND THE PROCEDURE CONTINUED SUCCESSFULLY. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509310 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482951

    Patients

    Seq Age Sex Outcome Treatment
    1