BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 6731779 · Received July 21, 2017

    Report

    Report Number
    1820334-2017-01808
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 23, 2017
    Report Date
    January 25, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION / INVESTIGATION: A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS PERFORMED. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION IN THE CLOSED POSITION. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS LOOSE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 2.5 CM IN LENGTH. THE SUPPORT SHEATH AND THE BASKET SHEATH ARE STILL ADHERED. A VISUAL EXAMINATION NOTED THE SUPPORT SHEATH TO BE PARTIALLY SEPARATED 1 MM PAST THE NOSE OF THE MLLA. THE BASKET FORMATION IS NOT VISIBLE. THE SUPPORT SHEATH IS BOWED IN APPEARANCE. THE BASKET SHEATH IS BOWED IN THE DISTAL TIP ABOUT 2 CM. THERE ARE SEVERAL KINKS NOTED IN THE BASKET SHEATH; ONE AT 24.2 CM FROM DISTAL TIP OF THE SUPPORT SHEATH AND ANOTHER KINK AT 37 CM FROM THE DISTAL TIP OF THE SUPPORT SHEATH, AGAIN AT 40.5 CM, 48.5 CM, 62.5 CM FROM THE DISTAL TIP OF THE SUPPORT SHEATH. A KINK WAS ALSO FOUND 1 CM FROM THE DISTAL TIP OF THE BASKET SHEATH. THE CUSTOMER COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. 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 THERE WERE NO NON-CONFORMANCES NOTED RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINTS HISTORY REVEALED THIS IS THE ONLY COMPLAINT RECEIVED FOR COMPLAINT LOT NUMBER 7895525. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION EVALUATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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

    CONCOMITANT MEDICAL PRODUCT: STORZ FLEXIBLE URETEROSCOPE. (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

    IT WAS REPORTED THAT THE EXTRACTOR WAS DEFECTIVE. THE STONE EXTRACTOR STOPPED WORKING AFTER TWO TIMES AND IT COULD NOT BE OPENED ANYMORE. ANOTHER STONE EXTRACTOR WAS USED AND THERE WERE NO REPORTED ADVERSE EFFECTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512336 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1