BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6871989 · Received September 18, 2017

    Report

    Report Number
    1820334-2017-03236
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    September 13, 2017
    Report Date
    January 10, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: PATIENT GENDER ¿ MALE. DOCTOR WAS PERFORMING A FLEXIBLE URETEROSCOPY TO RETRIEVE A KIDNEY STONE. INVESTIGATION ¿ EVALUATION THE NGAGE NITINOL STONE EXTRACTOR WAS NOT RETURNED FOR EVALUATION. NO PHOTOS HAVE BEEN PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A DOCUMENT-BASED INVESTIGATION/EVALUATION WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED FOR THE COMPLAINT LOT 7992496. A REVIEW OF COMPLAINT HISTORY FOR THIS DEVICE LOT FOUND THAT THIS IS THE ONLY COMPLAINT THAT HAS BEEN REPORTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (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 USER FACILITY REPORTED THE SPRING IS BLOCKED AND IT IS IMPOSSIBLE TO DEPLOY THE FORCEPS OF THE NGAGE NITINOL STONE EXTRACTOR. THEY HAD TO USE ANOTHER DEVICE. THERE WERE NO CONSEQUENCES TO THE PATIENT. ADDITIONAL EVENT, PATIENT AND DEVICE INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652965 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1