BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6750963 · Received July 28, 2017

    Report

    Report Number
    1820334-2017-01856
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 10, 2017
    Report Date
    January 26, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE NGAGE NITINOL STONE EXTRACTOR HAS NOT BEEN RETURNED AND NO PHOTOGRAPHS WERE PROVIDED. THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED. THE INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND QUALITY CONTROL DATA. 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. CURRENT CONTROLS ARE IN PLACE IN MANUFACTURING TO ASSURE DEVICE FUNCTIONALITY PRIOR TO SHIPPING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES TO BE ASSOCIATED WITH THE DEVICE LOT NUMBER 7668250. A REVIEW OF COMPLAINT HISTORY FOR THE COMPLAINT PRODUCT AND LOT NUMBER COMBINATION REVEALED THAT THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED. BASED ON THE INFORMATION AVAILABLE AND WITHOUT THE DEVICE; A ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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 BY THE CUSTOMER, WHILE PREPARING THE NGAGE NITINOL STONE EXTRACTOR FOR USE IN A CYSTOURETHROSCOPY LASER LITHOTRIPSY WITH STENT INSERTION THE EXTRACTOR WOULD NOT OPEN AND CLOSE. THE EXTRACTOR WAS PUT ASIDE AND REPLACEMENT NGAGE NITINOL STONE EXTRACTOR WAS OPENED AND USED TO PERFORM THE PROCEDURE. THE NON-FUNCTIONAL DEVICE DID NOT COME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532057 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482951

    Patients

    Seq Age Sex Outcome Treatment
    1