BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 7138866 · Received December 21, 2017

    Report

    Report Number
    1820334-2017-04341
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    March 1, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND 2 NONCONFORMANCE ISSUES. QUANTITY OF 1 FAILED TEST, TENSILE, NON-DESTRUCTIVE WAS SCRAPPED AND QUANTITY OF 5 QUANTITY, INCORRECT WERE REWORKED. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT # 8010721. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT AND SECURE. THE MLLA (MALE LUER LOCK ADAPTOR) IS TIGHT. THE PETT MEASURES 2.5 CM IN LENGTH. A FUNCTIONAL TEST DETERMINED THAT THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. A VISUAL EXAMINATION NOTED THE SUPPORT SHEATH IS SLIGHTLY BOWED IN APPEARANCE. TWO OF THE BASKET WIRES ARE NO LONGER ATTACHED. ONE OF THE BASKET WIRES HAS PULLED OUT OF THE CANNULATED HANDLE, ONE OF THE WIRES IS BROKEN FLUSH TO THE DISTAL TIP OF THE BASKET SHEATH. THE BASKET FORMATION COULD NOT BE MANUALLY ACTUATED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. 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. 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. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FROM THE FACILITY WITH NO INFORMATION REGARDING THE DETAILS AROUND THE DEVICE. UPON INSPECTION OF THE DEVICE, IT WAS FOUND TO HAVE TWO BROKEN WIRES IN THE BASKET FORMATION. WE CONTACTED THE FACILITY AND WERE UNABLE TO OBTAIN ADDITIONAL INFORMATION. THE FACILITY CONTACT PERSON WE SPOKE WITH ADVISED THE FACILITY DOES NOT RECORD OR NOTE ALLEGED FAULTY DEVICES UNLESS THERE WAS PATIENT HARM. THE FACILITY REPRESENTATIVE STATED SHE HAD NO RECORD OF AN EVENT AROUND THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919396 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002187788

    Patients

    Seq Age Sex Outcome Treatment
    1