BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8136865 · Received December 6, 2018

    Report

    Report Number
    1820334-2018-03513
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 19, 2018
    Report Date
    December 14, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION 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 STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE LOT NUMBER 9171173. VISUAL EXAMINATION NOTED THAT DEVICE WAS RETURNED WITH THE BASKET FORMATION SEVERED BEHIND THE DISTAL CANNULA. THERE IS DISCOLORATION AT THE BASE OF THE BASKET FORMATION. THE BASE OF THE BASKET FORMATION IS BENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 9171173 FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. 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. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING INCLUDING A PULL TEST OF THE BASKET ASSEMBLY. THE COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT HAD SEPARATED FROM THE DEVICE. THE TWO WIRES THAT HOLD THE BASKET TO THE DEVICE WERE FOUND TO BE BROKEN PROXIMAL TO THE BASKET CANNULA. THE BROKEN ENDS OF THE WIRES WERE NECKED DOWN, INDICATING THE WIRES BROKE DUE TO A LARGE TENSILE FORCE BEING APPLIED TO THEM. IT WAS ALSO OBSERVED THAT THE FOUR BASKET WIRES WERE SEVERELY BENT NEAR THE PROXIMAL END OF THE BASKET. THE EXTENT OF THE DAMAGE TO THE RETURNED DEVICE MAKES IT LIKELY IT WAS EXPOSED TO FORCES LARGE ENOUGH TO CAUSE THE OBSERVED DAMAGE. THE DAMAGE WAS PROBABLY INADVERTENTLY CAUSED DURING USE OF THE DEVICE. 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 WITH STONE EXTRACTION PROCEDURE, THE TIP OF THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET BROKE OFF. THE BASKET PORTION BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PORTION WITH ANOTHER EXTRACTOR, AND COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976229 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9171173 00827002187788

    Patients

    Seq Age Sex Outcome Treatment
    1