BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    MDR report key: 8121334 · Received November 30, 2018

    Report

    Report Number
    1820334-2018-03445
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 9, 2018
    Report Date
    December 13, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002191105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. INVESTIGATION: EVALUATION: A VISUAL INSPECTION 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 STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE LOT NUMBER: 9190218. VISUAL EXAMINATION NOTED THE DEVICE WAS RETURNED IN 2 SEGMENTS. THE BASKET SHEATH PROXIMAL SEGMENT MEASURES 59.5 CM IN LENGTH. THE BASKET SHEATH DISTAL SEGMENT MEASURES 55.3 CM IN LENGTH. THE BASKET FORMATION AND THE DISTAL COIL ASSEMBLY WERE NOT RETURNED. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE OPEN POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS LOOSE. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3 CM IN LENGTH. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT: 9190218 FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER: 9190218. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): PRECAUTION SECTION: ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR. 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. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING. THE COMPLAINT DEVICE WAS FOUND TO HAVE SEPARATED NEARLY IN HALF, WITH THE SHEATH AND COIL WIRE BOTH SEPARATED. THE DISTAL PORTION OF THE SEPARATED SHEATH WAS RETURNED, BUT THE DISTAL PORTION OF THE COIL WIRE (WITH THE BASKET) WAS NOT RETURNED. THE DEVICE WAS LIKELY INADVERTENTLY DAMAGED, DURING HANDLING / USE OF THE DEVICE CAUSING THE SEPARATION OF THE BASKET SHEATH AND COIL WIRE. 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/510K # ¿ 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, DURING A URETEROSCOPY, WHILE THEY WERE REMOVING STONES, THE DEVICE CAME APART. ONE OF THE WIRES ON THE BASKET BROKE FROM THE CONNECTION. ANOTHER BASKET WAS USED TO REMOVE ALL PIECES AND TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958815 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9190218 00827002191105

    Patients

    Seq Age Sex Outcome Treatment
    1