BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 7943420 · Received October 8, 2018

    Report

    Report Number
    1820334-2018-03123
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    October 3, 2018
    Report Date
    November 8, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002328624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS COMPLAINT DEVICE LOT NUMBER 9031300. FUNCTIONAL TESTING NOTED THE HANDLE ACTUATES THE BASKET FORMATION TO FULLY DEPLOYED POSITION AND SLOWLY RETRACTS. THE DEVICE WAS REMOVED FROM THE SHEATH AND REPLACED. FUNCTIONAL TESTING WAS AGAIN PERFORMED AND NOTED THE SAME RESULTS. THE RETURNED DEVICE WAS FOUND TO NOT TO HAVE ANY DAMAGE TO THE BASKET AND WAS FULLY FUNCTIONAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THIS REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9031300. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. 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 AND ARE PACKAGED WITH THE BASKET OPEN. THE IFU CONTAINS CAUTIONS ABOUT MANIPULATING THE DEVICE TO PREVENT DAMAGE. THE COMPLAINT DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO DAMAGE. THE COMPLAINT COULD NOT BE CONFIRMED. THE INVESTIGATION CONCLUSION IS NO PROBLEM WAS DETECTED. 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/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 A STONE EXTRACTION PROCEDURE AND PRIOR TO USE, WHILE TRYING TO DEPLOY THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR THE TIP OF THE BASKET WAS BENT. A SECOND PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR WAS TESTED PRIOR TO USE. WHEN TRYING TO DEPLOY IT, THE TIP OF THE BASKET WAS BENT. A THIRD OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE TWO BENT BASKETS WERE NOT USED. THERE WAS NO PATIENT CONTACT. THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. THE FIRST BASKET TIP BENT WHILE TRYING TO DEPLOY REPORTED IN MANUFACTURER REPORT # 1820334-2018-03122 AND THE SECOND BASKET TIP BENT REPORTED IN THIS MANUFACTURER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785379 PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9031300 00827002328624

    Patients

    Seq Age Sex Outcome Treatment
    1