BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7376952 · Received March 28, 2018

    Report

    Report Number
    1820334-2018-00817
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 3, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT. THE MALE LUER LOCK ADAPTOR (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.5 CM IN LENGTH. A VISUAL EXAMINATION NOTED THE SUPPORT SHEATH IS SEVERED IN TWO PLACES. THE FIRST IS LOCATED AT 2 CM FROM NOSE OF THE MLLA AND WAS PARTIALLY SEVERED AND STILL ADHERED TO THE BASKET SHEATH. THE SECOND IS LOCATED AT 3 CM FROM THE NOSE OF THE MLLA AND IS COMPLETELY SEVERED AND DETACHED FROM THE BASKET SHEATH. A FUNCTIONAL TEST DETERMINED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. THE HANDLE WAS DISASSEMBLED AND THE BASKET FORMATION CAN BE MANUALLY ACTUATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE FAILURE MODE OF SHEATH DAMAGE. A REVIEW OF COMPLAINT HISTORY REVEALED ONE OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 7021336 FOR A SIMILAR ISSUE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING RELEVANT 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. CURRENT CONTROLS ARE IN PLACE IN MANUFACTURING TO ASSURE DEVICE FUNCTIONALITY PRIOR TO SHIPPING. THE COMPLAINT DEVICE WAS FOUND TO BE NON-FUNCTIONAL DUE TO SHEATH DAMAGE. THE SHEATH WAS FOUND TO BE DAMAGED IN TWO LOCATIONS NEAR THE HANDLE. DEVICES ARE INSPECTED FOR DAMAGE AND FUNCTIONALITY PRIOR TO PACKAGING. THE OBSERVED DAMAGE LIKELY OCCURRED DURING USE OF THE DEVICE. 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

    IT WAS REPORTED DURING PREOPERATIVE TESTING, THE BASKET ON A NGAGE NITINOL STONE EXTRACTOR WAS UNABLE TO OPEN OR CLOSE. AN ALTERNATIVE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SCHEDULED URETEROSCOPY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222726 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1