BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6854698 · Received September 11, 2017

    Report

    Report Number
    1820334-2017-02864
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 21, 2017
    Report Date
    November 29, 2017
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DEVICE AVAILABLE FOR EVALUATION CHANGED FROM "NO" TO "YES". INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, SPECIFICATIONS, AND QUALITY CONTROL WAS PERFORMED. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION PARTIALLY OPENED. THE COLLET KNOB WAS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS FINGER TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.5 CM IN LENGTH. A FUNCTIONAL TEST DETERMINED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. A VISUAL EXAMINATION NOTED THE BASKET SHEATH IS SMASHED APPROXIMATELY 3MM FROM THE DISTAL TIP OF THE SUPPORT SHEATH. THE COMPLAINT IS CONFIRMED. 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 1 NON-CONFORMANCE NOTED FOR FLARE BROKE AND THE PRODUCT WAS SCRAPPED. A REVIEW OF COMPLAINT HISTORY FOUND THIS TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED WITH THIS PRODUCT LOT NUMBER 7505514. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. 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

    THE DISTRIBUTOR REPORTED THE NGAGE NITINOL STONE EXTRACTOR PACKAGE WAS OPENED IN PREPARATION FOR USE IN AN URETERORENOSCOPY PROCEDURE. ONCE THE DEVICE WAS TAKEN OUT OF THE PACKAGE, THE BASKET WAS TESTED BY OPENING AND CLOSING IT. AFTER TESTING, THE BASKET WOULD NOT OPEN AGAIN AND IT WAS NOTED THAT THE HANDLE WAS LOOSE. THIS STONE EXTRACTOR WAS NOT USED AND IT DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636160 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482968

    Patients

    Seq Age Sex Outcome Treatment
    1