BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NFORCE NITINOL HELICAL STONE EXTRACTOR

    MDR report key: 8698427 · Received June 13, 2019

    Report

    Report Number
    1820334-2019-01384
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 30, 2019
    Report Date
    July 24, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002179400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE DEVICE AND TWO EMPTY PACKAGES WERE RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED COMPLAINT DEVICE LOT NUMBER. INSPECTION OF THE RETURNED DEVICE NOTED THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND BASKET FORMATION WAS IN THE OPEN POSITION. A VISUAL EXAMINATION NOTES THE BASKET FORMATION WAS PROTRUDING FROM THE END OF THE BASKET SHEATH 1 CM WITH THE BASKET FORMATION CLOSED. FUNCTIONAL TESTING NOTED THE HANDLE ACTUATED THE BASKET FORMATION, BUT DID NOT FULLY RETRACT THE BASKET FORMATION INTO THE BASKET SHEATH. THE BASKET SHEATH WAS ACCORDIONED STARTING 5 MM FROM THE DISTAL END OF THE SUPPORT SHEATH AND EXTENDS FOR A LENGTH OF 5 MM. DURING THE ACTUATION OF THE HANDLE, THE BASKET SHEATH AND SUPPORT SHEATH DETACHED, AND THE HANDLE COULD NO LONGER ACTUATE THE BASKET FORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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 RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT WAS NON FUNCTIONAL DUE TO SHEATH DAMAGE. THE SHEATH WAS COLLAPSED (ACCORDION) NEAR THE HANDLE. THE DAMAGED SHEATH WAS PREVENTING THE BASKET FROM OPENING AND CLOSING PROPERLY. THE INFORMATION PROVIDED BY THE USER STATED THE ISSUE OCCURRED BEFORE USE. THE COLLAPSED BASKET SHEATH LIKELY OCCURRED DUE TO THE BASKET BEING CLOSED WHILE THE SHEATH WAS IN A COILED POSITION. WHEN IN A TORTUOUS PATH, EITHER DURING OR BEFORE USE, CLOSING THE BASKET CAN PLACE A LARGE COMPRESSIVE FORCE ON THE SHEATH, CAUSING IT TO COLLAPSE NEAR THE HANDLE. THERE WAS NO INFORMATION PROVIDED RELATED TO HANDLING OF THE DEVICE, SO IT COULD NOT BE CONFIRMED THAT THE DEVICE WAS DAMAGED DUE TO HANDLING BEFORE USE, BUT IT IS A POSSIBLE CAUSE. THE TWO NON-RETURNED DEVICES WERE ASSUMED TO HAVE THE SAME ISSUE AS THE RETURNED DEVICE. THE CAUSE FOR THE OBSERVED SHEATH DAMAGE COULD NOT BE DETERMINED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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

    ADDITIONAL INFORMATION WAS RECEIVED 27JUN2019: A TOTAL OF THREE DEVICES WERE TESTED PRIOR TO PATIENT CONTACT AND ALL THREE WOULD NOT OPEN AND CLOSE. THE THREE DEVICES WERE FROM THE SAME LOT NUMBER (8974858). THE PROCEDURE WAS COMPLETED WITH A COMPETITORS' DEVICE.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: UROLOGY COORDINATOR. 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 IS REPORTED PRIOR TO A URETEROSCOPY OF THE URINARY SYSTEM USING A NFORCE NITINOL HELICAL STONE EXTRACTOR, THE COMPLAINT DEVICE WOULD NOT OPEN AND CLOSE. THIS WAS TESTED PRIOR TO PATIENT CONTACT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AFTER THE DIFFICULTY. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. ADDITIONAL DETAILS REGARDING THE PATIENT AND THE EVENT HAVE BEEN REQUESTED. THE CUSTOMER STATED THAT THEY HAVE NO ADDITIONAL INFORMATION TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490962 NFORCE NITINOL HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G17940 8974858 00827002179400

    Patients

    Seq Age Sex Outcome Treatment
    1