BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7261579 · Received February 9, 2018

    Report

    Report Number
    1820334-2018-00086
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 8, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: THE INVESTIGATION PERFORMED FOR THIS COMPLAINT REPORT INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND SPECIFICATIONS. NO ISSUES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED COMPLAINT. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS ALSO CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TEST NOTED THE HANDLE ACTUATED THE BASKET FORMATION. A VISUAL EXAMINATION NOTED ONE OF THE WIRES IN THE BASKET FORMATION IS BROKEN. CUSTOMER STATED PRIOR TO USE, HOWEVER BIO-MATTER WAS NOTED ON THE BASKET FORMATION. THE BASKET IS BROKEN INSIDE THE SHEATH. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY FOUND THIS TO BE THE ONLY COMPLAINT ASSOCIATED WITH PRODUCT LOT NUMBER 7953126. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. 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. THESE DEVICES ARE 100% INSPECTED FOR FUNCTIONALITY AND INTEGRITY BEFORE PACKAGING. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), WHICH STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE 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 A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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)(6). (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, WHEN THE PACKAGE OF A NGAGE NITINOL STONE EXTRACTOR WAS OPENED THEY FOUND ONE OF THE WIRES WAS OFF FROM THE DEVICE MAIN BODY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104174 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482968

    Patients

    Seq Age Sex Outcome Treatment
    1