BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 8169815 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03781
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    December 10, 2018
    Report Date
    January 15, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS DEVICE LOT NUMBER 8974785. THE COMPLAINT DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION BOTH IN THE CLOSED POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.7 CM IN LENGTH. FUNCTIONAL TESTING DETERMINED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. VISUAL EXAMINATION NOTED THERE ARE NO KINKS IN THE BASKET SHEATH. THE SUPPORT SHEATH AND THE BASKET SHEATH ARE DETACHED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS WITH THE COMPLAINT DEVICE LOT NUMBER 8974785. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING: 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 COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WAS CLOSED AND WOULD NOT OPEN DUE TO SHEATH DAMAGE. THE BASKET SHEATH HAD SEPARATED FROM THE ORANGE SUPPORT SHEATH AT THE HANDLE. THE TWO SHEATHS ARE GLUED TOGETHER, BUT HAD SEPARATED IN THE COMPLAINT DEVICE. THE DEVICE WAS TESTED FOR BASKET FUNCTION DURING MANUFACTURING AND DURING THE QUALITY CONTROL CHECK PERFORMED AFTERWARDS. THE QUALITY CONTROL CHECK ALSO INCLUDES A STEP TO CHECK THAT THE BASKET SHEATH AND SUPPORT SHEATH ARE SECURE. THE CHECKS PERFORMED DURING MANUFACTURE AND THE QUALITY CONTROL STEP INDICATE THE DEVICE WAS FUNCTIONAL WHEN PRODUCED. IT WAS NOTED THE RETURNED DEVICE HAD THE BASKET CLOSED. THE DEVICE WAS PACKAGED WITH THE BASKET OPEN, THEREFORE THE DEVICE FUNCTIONED WHEN CLOSING THE BASKET. THE SEPARATION OF THE BASKET SHEATH AND SUPPORT SHEATH PREVENTED THE BASKET FROM FUNCTIONING NORMALLY. IT IS LIKELY THE SHEATHS BECAME SEPARATED DUE TO BEING INADVERTENTLY DAMAGED DURING UNPACKING / HANDLING OF THE DEVICE. THE INVESTIGATION CONCLUSION IS CAUSE TRACED TO USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. 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. 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

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR BASKET WAS UNABLE TO OPEN PRIOR PATIENT CONTACT. ACCORDING TO END USER, SHE OPENED A NEW NGAGE NITINOL STONE EXTRACTOR IN ORDER TO CONTINUE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007974 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 8974785 00827002482944

    Patients

    Seq Age Sex Outcome Treatment
    1