BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8247855 · Received January 15, 2019

    Report

    Report Number
    1820334-2019-00124
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 15, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION BOTH IN THE OPEN POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. FUNCTIONAL TESTING DETERMINED THE HANDLE RETRACTED THE BASKET FORMATION, BUT IT DOES NOT EXTRACT THE BASKET FORMATION. VISUAL EXAMINATION NOTED NO KINKS IN THE BASKET SHEATH. THE CANNULATED HANDLE IS BENT AT THE NOSE OF THE MLLA. THE SUPPORT SHEATH AND BASKET SHEATH ARE STILL ADHERED. 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 REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS WITH THE COMPLAINT DEVICE LOT NUMBER 9190166. 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. THE COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WAS CLOSED AND COULD NOT BE OPENED FULLY DUE TO SHEATH DAMAGE. THE SHEATH WAS DAMAGED NEAR THE HANDLE, 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 HANDLING / USE. THE INVESTIGATION CONCLUSION IS CAUSE TRACED TO USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. 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/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 THAT WHILE PREPARING FOR A TRANSURETHRAL URETEROLITHOTOMY (TUL) USING A NCIRCLE TIPLESS STONE EXTRACTOR, A KINK WAS NOTED IN THE PURPLE SAFETY SHEATH NEAR THE HANDLE DEVICE WHEN IT WAS REMOVED FROM THE PACKAGE. A SECOND BASKET WAS USED INSTEAD TO COMPLETE THE CASE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE FAILURE ANALYSIS REVEALED THAT THE BASKET WOULD NOT OPEN OR CLOSE. EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF F BASKET NOT OPENING AND CLOSING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41314 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9190166 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1