BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCOMPASS NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 7899279 · Received September 21, 2018

    Report

    Report Number
    1820334-2018-02704
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    July 12, 2018
    Report Date
    September 28, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002327016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K #: EXEMPT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. (B)(6); (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE BETWEEN THE OPEN AND CLOSED POSITIONS AND THE BASKET FORMATION IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTER (MLLA) IS FINGER TIGHT. A VISUAL EXAMINATION NOTED THE SUPPORT SHEATH IS BOWED IN APPEARANCE. WITH THE HANDLE IN THE OPEN POSITION, THERE IS 2 CM OF THE COIL ASSEMBLY EXPOSED AT THE DISTAL TIP. A FUNCTIONAL TEST DETERMINED, THE HANDLE WILL OPEN THE BASKET FORMATION, BUT DOES NOT RETRACT THE BASKET FORMATION. THE SUPPORT SHEATH AND BASKET SHEATH ARE DETACHED; ADHESIVE WAS NOTED ON THE BASKET SHEATH. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7910320. AS FOUND IN THE INSTRUCTIONS FOR USE (IFU): PRECAUTION SECTION: ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR. 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. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING AND ARE PACKAGED WITH THE BASKET OPEN. THE IFU CONTAINS CAUTIONS ABOUT MANIPULATING THE DEVICE TO PREVENT DAMAGE. THE COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WAS OPEN AND COULD NOT BE CLOSED DUE TO SHEATH DAMAGE. THE SHEATH WAS DAMAGED AND SEPARATED NEAR THE HANDLE, PREVENTING THE BASKET FROM FUNCTIONING. THE CONDITION OF THE RETURNED DEVICE MAKES IT POSSIBLE THAT IT WAS INADVERTENTLY DAMAGED DURING UNPACKING / HANDLING. SINCE NO INFORMATION RELATED TO PRODUCT HANDLING IS AVAILABLE, A CONCLUSIVE CAUSE FOR THE FAILURE COULD NOT 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.

    Description of Event or Problem · 1

    THE UF REPORT (B)(4) WAS RECEIVED AND THE REPORT SHOWED THE CUSTOMER REPORTED, DURING A HOLIUM LASER STENT PLACEMENT PROCEDURE, AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS OPENED BUT WOULD NOT RETRACT IN ORDER TO GET INTO THE SCOPE. THE MEDICAL DOCTOR DEEMED THE PRODUCT AS DEFECTIVE. ANOTHER ITEM WAS OBTAINED AND USED TO COMPLETE THE CASE. PRODUCT DID NOT HAVE PATIENT CONTACT OR PATIENT HARM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740644 NCOMPASS NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 7910320 00827002327016

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR