BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7265125 · Received February 12, 2018

    Report

    Report Number
    1820334-2018-00216
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    March 17, 2017
    Report Date
    March 15, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A DOCUMENTATION REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND DEVICE SPECIFICATIONS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE FIVE NON-CONFORMANCE ISSUES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. THE ISSUES IDENTIFIED WERE: COMPONENT, MISSING- QTY 2, DOES NOT FUNCTION- QTY 2, SURFACE, DEFECT- QTY 1, FOREIGN MATTER- QTY 1, AND TIP/TAPER INADEQUATE INCOMPLETE- QTY 1. ALL OF THE NON-CONFORMING ITEMS WERE SCRAPPED OR REWORKED. A SEARCH OF COMPLAINT HISTORY RECORDS REVEALED ONE ADDITIONAL COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7142082. THE COMPLAINT WAS FOR A SIMILAR ISSUE ¿THE BASKET DID NOT OPEN¿. 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. ALL DEVICES ARE 100% INSPECTED FOR FUNCTIONALITY AND INTEGRITY BEFORE PACKAGING. THE INSTRUCTIONS FOR USE (IFU) CONTAINS A CAUTION TO NOT USE EXCESSIVE FORCE TO MANIPULATE THE DEVICE, OR DAMAGE TO THE DEVICE MAY OCCUR. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION EVALUATION A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THE REPORTED 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). PMA/510K # ¿ EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASKET OF THE NGAGE NITINOL STONE EXTRACTOR DID NOT OPEN CORRECTLY WHEN THE NURSE CHECKED IT PRIOR TO A FLEXIBLE URETEROSCOPY TO RETRIEVE A STONE FRAGMENT IN THE KIDNEY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO ADVERSE EVENT REPORTED. THE CUSTOMER REPORTED THAT THEY WOULD NOT BE RETURNING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107439 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1