BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 7752982 · Received August 6, 2018

    Report

    Report Number
    1820334-2018-02355
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 30, 2018
    Report Date
    September 20, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: EVALUATION CONCLUSION CODES: CAUSE CANNOT BE TRACED TO DEVICE (4310), ADVERSE EVENT RELATED TO PROCEDURE (4311). INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED WHICH INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE CLOSED POSITIONS. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTER (MLLA) IS LOOSE. A FUNCTIONAL TEST DETERMINED THE HANDLE ACTUATED THE BASKET FORMATION TO THE OPEN AND CLOSED POSITIONS. VISUAL EXAMINATION NOTED THE SUPPORT SHEATH IS BOWED AT THE NOSE OF THE MLLA. THE BASKET SHEATH IS KINKED 1.2 CM FROM THE DISTAL TIP. ONE WIRE FROM THE BASKET FORMATION WAS FOUND TO BE PULLED LOOSE FROM THE DISTAL CANNULA; THE OTHER THREE WIRES WERE NOTED TO BE SECURE BUT APPEARED CROSSED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT WOULD CAUSE OR CONTRIBUTE TO THE COMPLAINT FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 8853419. THE INSTRUCTIONS FOR USE (IFU) PRECAUTION SECTION PROVIDES THE FOLLOWING: 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. 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 RETURNED DEVICE WAS FOUND TO HAVE 1 OF THE 4 BASKET WIRES PULLED FREE FROM THE BASKET CANNULA THAT HOLDS THE PROXIMAL END OF THE BASKET WIRES TOGETHER. THE EVENT INFORMATION STATED THE STONE BEING REMOVED WAS LARGE. IT IS POSSIBLE THE LARGE SIZE OF THE STONE PLACE ABNORMAL FORCE ON THE BASKET WIRES, CAUSING ONE OF THEM TO PULL OUT OF THE BASKET CANNULA. THE CAUSE FOR THIS ISSUE CANNOT BE TRACED TO THE DEVICE, IT IS RELATED TO THE PROCEDURE. 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)(4). PMA/510K # ¿ EXEMPT. 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 STONE EXTRACTION PROCEDURE, WHILE ATTEMPTING TO EXTRACT A LARGE STONE, ONE OF THE BASKET WIRES OF THE NCIRCLE TIPLESS STONE EXTRACTOR BROKE. NOTHING DETACHED INSIDE THE PATIENT. ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593058 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 8853419 00827002187788

    Patients

    Seq Age Sex Outcome Treatment
    1 STORZ FLEXIBLE URETERSCOPE