BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 7070167 · Received November 30, 2017

    Report

    Report Number
    1820334-2017-04192
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 23, 2017
    Report Date
    November 29, 2017
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION / INVESTIGATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, MANUFACTURING INSTRUCTIONS, 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 AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS LOOSE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 1.5 CM. A VISUAL EXAMINATION NOTED A KINK IN THE BASKET SHEATH 38 CM FROM THE DISTAL TIP OF THE BASKET SHEATH. A FUNCTIONAL TEST NOTED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. THE BASKET FORMATION WAS FOUND TO APPEAR COLLAPSED. THE KNOT AT THE END OF THE BASKET FORMATION HAS COME LOOSE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THERE WERE THREE NON-CONFORMANCE ISSUES NOTED. THREE ITEMS FOUND WITH BASKET SHAPE INCORRECT, THREE FAILED TEST, TENSILE, NON-DESTRUCTIVE AND ONE ITEM WITH LABELS APPLIED INCORRECTLY. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THIS IS THE ONLY COMPLAINT ASSOCIATED TO LOT NUMBER 8170355. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. 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. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE. 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

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE, THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET WOULD NOT GRAB PATIENT'S STONE. IT WAS STATED THE HEAD OF THE BASKET WAS DEFECTIVE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849274 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002187771

    Patients

    Seq Age Sex Outcome Treatment
    1 63 DA