BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 7128221 · Received December 19, 2017

    Report

    Report Number
    1820334-2017-04600
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 4, 2017
    Report Date
    February 28, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVALUATION / INVESTIGATION: A VISUAL INSPECTION 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 PARTIALLY OPENED AND THE BASKET FORMATION IS CLOSED. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 2.5 CM. A VISUAL EXAMINATION NOTED THE SUPPORT SHEATH AND THE BASKET SHEATH ARE DETACHED. ADHESIVE IS VISIBLE ON THE BASKET SHEATH. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THERE WERE NO NON-CONFORMANCES NOTED. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THIS IS THE ONLY COMPLAINT ASSOCIATED WITH DEVICE LOT NUMBER 8190345. 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. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 URETEROSCOPY KIDNEY STONE EXTRACTION PROCEDURE, THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET WAS NOT OPENING AND CLOSING COMPLETELY. THE NITINOL WIRE SEEMED TO STRETCH IN LENGTH AND WAS GETTING THINNER AND THE OUTER SHEATH BROKE OFF FROM THE HANDLE. ANOTHER NCIRCLE TIPLESS STONE EXTRACTOR WAS USED TO COMPLETE THE PROCEDURE. 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
    908090 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1