BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    MDR report key: 8184821 · Received December 20, 2018

    Report

    Report Number
    1820334-2018-03790
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 28, 2018
    Report Date
    January 30, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002191105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND TRENDS. ONE DEVICE RETURNED TO MANUFACTURER FOR INVESTIGATION. RETURNED PACKAGING CONFIRMS LOT NUMBER 8980772. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE OPENED POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS FINGER TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3 CM IN LENGTH. FUNCTIONAL TESTING DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION; HOWEVER, WITH THE HANDLE IN THE OPENED POSITION, 3 MM OF THE DISTAL CANNULA IS EXPOSED. VISUAL EXAMINATION NOTES THE BASKET SHEATH IS BOWED STARTING 2 CM FROM THE NOSE OF THE MLLA. THE BASKET SHEATH IS DAMAGED AT THE DISTAL END OF THE SUPPORT SHEATH. THE HANDLE WAS DISASSEMBLED, THEN RESET AND REASSEMBLED. THEN THE DEVICE FUNCTIONED AS INTENDED. IT IS POSSIBLE THE CANNULATED HANDLE SLIPPED INSIDE THE HANDLE. THE DEVICE NOW MEETS SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS THERE ARE NO OTHER COMPLAINTS THAT HAVE BEEN ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8980772. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTIONS: PRECAUTION: ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. PRECAUTION: 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. THE COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WOULD NOT CLOSE FULLY DUE TO SHEATH DAMAGE. THE SHEATH WAS KINKED / BOWED IN MULTIPLE LOCATIONS, PREVENTING THE BASKET FROM FUNCTIONING. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING AND ARE PACKAGED WITH THE BASKET OPEN. THE CONDITION OF THE RETURNED DEVICE MAKES IT POSSIBLE THAT IT WAS INADVERTENTLY DAMAGED DURING UNPACKING / HANDLING OF THE DEVICE, BUT IT IS ALSO POSSIBLE THE DEVICE WAS DAMAGED WHEN RECEIVED BY THE USER. THE DEFINITIVE CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE DETERMINED. 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

    (B)(6). PMA/510(K) #: 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 PREPARATION FOR A STONE EXTRACTION FLEXIBLE URETEROSCOPY PROCEDURE, TWO NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTORS WERE OPENED AND TESTED PRIOR TO THE PROCEDURE. AS REPORTED, THE BASKET APPEARED TO HAVE A KINK IN THE WIRE SHAFT AND DID NOT PERFORM (OPEN AND CLOSE) TO THE EXPECTATIONS OF THE DOCTOR. THEREFORE, THE BASKETS WERE PLACED INSIDE A BAG WITH THE PACKAGING AND ANOTHER BASKET WAS TAKEN OFF THE SHELF TO COMPLETE THE PROCEDURE. THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. THE FIRST EXTRACTOR (LOT 9130160) CAPTURED IN MANUFACTURER REPORT # 1820334-2018-03788. SECOND EXTRACTOR (LOT 8980772) REPORTED IN THIS MANUFACTURER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023434 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 8980772 00827002191105

    Patients

    Seq Age Sex Outcome Treatment
    1