BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8090924 · Received November 20, 2018

    Report

    Report Number
    1820334-2018-03386
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 5, 2018
    Report Date
    January 11, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D10 INVESTIGATION ¿ EVALUATION THE COMPLAINT DEVICE WAS NOT RECEIVED FOR AN EVALUATION. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NON-CONFORMANCES NOTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9171139. THE INSTRUCTIONS FOR USE (IFU) STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. ACCORDING TO THE PRECAUTIONS SECTION IN THE IFU: ¿ ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. ¿ DO NOT USE EXCESSIVE FORCE TO MANIPULATE THE 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 AND ARE PACKAGED WITH THE BASKET OPEN. THE COMPLAINT DEVICE WAS NOT RETURNED, PREVENTING A DETERMINATION OF THE NATURE OF THE SEPARATED WIRE AND A DETERMINATION OF THE CAUSE. IT IS POSSIBLE THE WIRE HAD PULLED FREE FROM THE BASKET CANNULA, BROKEN DURING USE, OR WAS BROKEN DUE TO EXPOSURE TO A LASER. WITHOUT THE DEVICE, A CONCLUSION COULD NOT BE ESTABLISHED. 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

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 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 (URS) STONE EXTRACTION PROCEDURE, THE WIRE BROKE LOOSE FROM SHAFT HOUSING THAT HOLDS THE STONE IN THE BASKET. NO PIECE OF THE BASKET CAME OFF OF THE BASKET. ANOTHER BASKET WAS OPENED 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
    930586 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9171139 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1 STORZ FLEXIBLE URETEROSCOPE 3.6 FR