BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE HELICAL TIPLESS STONE EXTRACTOR

    MDR report key: 6906761 · Received October 2, 2017

    Report

    Report Number
    1820334-2017-03426
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 8, 2017
    Report Date
    February 15, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002181915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    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, DOCUMENTATION, DRAWINGS, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED IN USED CONDITION WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LURE LOCK ADAPTOR (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 2 CM IN LENGTH. A VISUAL EXAMINATION NOTED THE BASKET SHEATH AND THE SUPPORT SHEATH HAVE BECOME DETACHED; MINIMAL ADHESIVE WAS NOTED ON THE BASKET SHEATH. THE RETURNED DEVICE WAS FOUND TO BE NON-FUNCTIONAL DUE TO THE SHEATH SEPARATING FROM THE HANDLE. DEVICE ARE 100% TESTED FOR PROPER OPERATION AFTER MANUFACTURING. IT IS POSSIBLE THAT INSUFFICIENT GLUE WAS APPLIED TO THE SHEATH JOINT DURING MANUFACTURING, CAUSING THE SHEATH TO SEPARATE DURING USE. IT CANNOT BE CONFIRMED THAT INSUFFICIENT GLUE WAS APPLIED AS THERE ARE OTHER POTENTIAL CAUSES FOR THE OBSERVATION OF MINIMAL ADHESIVE: THERE MAY HAVE BEEN AN ISSUE WITH THE GLUE CURING PROCESS, OR THE GLUE MAY HAVE COME OFF AFTER THE SHEATH SEPARATED. 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. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY REPORTED COMPLAINT ASSOCIATED WITH THE COMPLAINT LOT NUMBER 7940888. THE ROOT CAUSE OF THIS EVENT IS MANUFACTURING RELATED; PROCESS RELATED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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 REPRESENTATIVE REPORTED, DURING AN URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE WHEN THE PHYSICIAN TRIED TO USE THE NCIRCLE HELICAL TIPLESS STONE EXTRACTOR TO GRAB THE STONE, THE BASKET WOULDN'T CLOSE. A NEW BASKET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT BECAUSE OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687409 NCIRCLE HELICAL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002181915

    Patients

    Seq Age Sex Outcome Treatment
    1