BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 8366015 · Received February 25, 2019

    Report

    Report Number
    1820334-2019-00492
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 25, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. D11: WOLF COBRA FLEXIBLE URETEROSCOPE AND OLYMPUS 12/14 ACCESS SHEATH. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF; COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE LABELED RPN NGE-017115-MB AND LABEL LOT NUMBER 9242019 WAS RECEIVED. THE DEVICE WAS RETURNED WITH THE HANDLE AND BASKET FORMATION IN THE CLOSED POSITION. THE MLLA [MALE LUER LOCK ADAPTER] WAS FOUND TO BE LOOSE AND THE COLLET KNOB WAS TIGHT AND SECURE. POLYETHYLENE TEREPHTHALATE TUBING [PETT] MEASURED 3.5 CM IN LENGTH. A FUNCTIONAL TEST DETERMINED THAT THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. THE HANDLE WAS DISASSEMBLED FOR OBSERVATION. A VISUAL INSPECTION FOUND THAT THE SUPPORT SHEATH AND BASKET SHEATH WERE STILL ATTACHED. A VISUAL INSPECTION UNDER MAGNIFICATION FOUND THAT THE BASKET SHEATH IS ADHERED TO THE CANNULATED HANDLE. THE CAUSE FOR THE BASKET SHEATH AND CANNULATED HANDLE BECOMING ADHERED COULD NOT BE DETERMINED. A MANUAL FUNCTION TEST DETERMINED THAT THE BASKET FORMATION COULD NOT BE MANUALLY ACTUATED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO RELATED NON-CONFORMANCES OCCURRED DURING THE PRODUCTION OF LOT NUMBER 9242019. A SEARCH OF COMPLAINT RECORDS FOUND NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 9242019. THE INSTRUCTIONS FOR USE (IFU) INCLUDED WITH THIS DEVICE CONTAINS THE FOLLOWING INFORMATION: CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE ASSIGNED LIKELY CAUSE CATEGORY FOR THIS FAILURE MODE IS - CAUSE NOT ESTABLISHED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 27FEB2019: IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY (URS), THE BASKET WORKED FOR 2-3 TIMES. FRAGMENTS WERE EXTRACTED. AFTER THE 4TH FRAGMENT WAS EXTRACTED, THE BASKET STOPPED WORKING AND WOULD NOT CLOSE PROPERLY. THE ISSUE WAS IDENTIFIED OUTSIDE OF THE PATIENT´S BODY. A SECOND, SAME TYPE DEVICE, WAS OPENED AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) # - EXEMPT. (B)(4). 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 AFTER EXTRACTING TWO FRAGMENTS THE NGAGE NITINOL STONE EXTRACTOR BASKET DID NOT CLOSE ANYMORE. THE PATIENT WAS NOT HARMED. ADDITIONAL PATIENT, DEVICE AND EVENT DETAILS HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159476 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9242019

    Patients

    Seq Age Sex Outcome Treatment
    1