BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8267965 · Received January 22, 2019

    Report

    Report Number
    1820334-2019-00198
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 25, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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, THE DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE RETURNED FOR INVESTIGATION. RETURNED PACKAGING CONFIRMS LOT NUMBER 8853421. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN OPENED POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 1.3 CM IN LENGTH. FUNCTION TESTING DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION. VISUAL EXAMINATION NOTED THE BASKET SHEATH AND SUPPORT SHEATH ARE STILL ADHERED. THERE IS A KINK IN THE BASKET SHEATH 66 CM FROM THE DISTAL TIP. TWO WIRES IN THE BASKET FORMATION ARE SEPARATED. BOTH WIRES ARE SEPARATED 1 CM FROM THE DISTAL CANNULA. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT 8853421 SHOWED THERE ARE NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT THAT HAS BEEN ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8853421. 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. TO CONCLUDE, VISUAL EXAM NOTED TWO WIRES IN THE BASKET FORMATION ARE SEPARATED 1 CM FROM DISTAL CANNULA. THE WIRES HAVE THE APPEARANCE OF BEING DAMAGED BY AN INSTRUMENT OF UNDETERMINED ORIGIN. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE CUSTOMER STATED THE BASKET WIRES WERE BROKEN INSIDE THE PACKAGE. THERE ARE MULTIPLE CHECKS FOR BASKET DAMAGE DURING MANUFACTURING, QUALITY CONTROL CHECKS, AND WHEN THE DEVICE IS PACKAGED. THE CAUSE FOR THE BROKEN WIRES COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # - 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 THE DISTRIBUTOR FOUND THE BASKET WIRE IS BROKEN INSIDE THE PACKAGE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61027 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 8853421 00827002187771

    Patients

    Seq Age Sex Outcome Treatment
    1