BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    MDR report key: 7209915 · Received January 22, 2018

    Report

    Report Number
    1820334-2018-00101
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    January 11, 2018
    Report Date
    March 9, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002191105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION / INVESTIGATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO CONDUCTED. ONE UNOPENED PACKAGE WAS RETURNED FOR INVESTIGATION. THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED. THE UNUSED DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT AND SECURED. THE MALE LUER LOCK ADAPTER (MLLA) IS LOOSE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.5 CM IN LENGTH. A FUNCTIONAL TEST NOTED THE HANDLE ACTUATED THE BASKET FORMATION TO THE OPEN POSITION BUT WHEN IN THE CLOSED POSITION, THE BASKET FORMATION EXTENDS 2 MM FROM END OF THE BASKET SHEATH. WITH THE BASKET FORMATION IN THE OPEN POSITION, 1 MM OF THE DISTAL CANNULA EXTENDS. THERE IS NO DAMAGE TO THE BASKET SHEATH AND NO PARTS ARE MISSING. A REVIEW OF THE DEVICE HISTORY RECORD FOR COMPLAINT DEVICE LOT NUMBER 8190316, REVEALED ONE NON-CONFORMING ITEM DURING MANUFACTURING. THE NON-CONFORMING ITEM WAS SCRAPPED. COMPLAINT HISTORY RECORDS WERE REVIEWED AND SHOWED THERE HAS BEEN ONE OTHER COMPLAINT RECEIVED ON THE COMPLAINT DEVICE LOT NUMBER 8190316. THE OTHER COMPLAINT IS FROM THE SAME USER FACILITY, HOWEVER THE REPORTED FAILURE MODE IS FOR NOT THE SAME. 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 RETURNED DEVICE WAS FOUND TO HAVE A TIP EXTENSION OF 2MM WHEN THE BASKET WAS CLOSED. THERE IS NO DAMAGE NOTED TO THE DEVICE. THE CAUSE FOR THE IMPROPER TIP EXTENSION COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A FLEXIBLE URETEROSCOPY PROCEDURE, THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BASKET COULDN'T CLOSE COMPLETELY AS HALF OF THE BASKET SEEMED TO REMAIN OUTSIDE THE EXTRACTOR'S SHEATH. A SECOND BASKET WAS USED AND SHOWED THE SAME FAILURE, AS WELL AS THE SURFACE OF THE SHEATH ON THE TIP WAS FOUND MISSING. IT WAS REPORTED THIS SITUATION OCCURRED A FEW TIMES WITH THIS SPECIFIC LOT AND REFERENCE PART NUMBER THEREFORE THE WHOLE STOCK WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54477 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002191105

    Patients

    Seq Age Sex Outcome Treatment
    1