BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA FIDUCIAL NEEDLE

    MDR report key: 4945728 · Received July 24, 2015

    Report

    Report Number
    1037905-2015-00312
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    NEU
    PMA / PMN Number
    K141356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE FOUR FIDUCIAL MARKERS SUPPLIED WITH THE DEVICE WERE STILL PRESENT IN THE DISTAL TIP. DURING A FUNCTIONAL TEST, THE NEEDLE WOULD NOT ADVANCE OR RETRACT. THE NEEDLE WAS REMOVED FROM THE SHEATH AND A BEND IN THE NEEDLE WAS NOTICED APPROXIMATELY 2 CM FROM THE DISTAL TIP APPROXIMATELY 2 MM OF THE FIRST FIDUCIAL WAS EXTENDED FROM THE DISTAL TIP. AN ADDITIONAL BEND WAS NOTICED AT 32 CM FROM THE PROXIMAL END OF THE NEEDLE WHEN THE NEEDLE WAS REMOVED FROM THE SHEATH. THE STYLET WAS REMOVED AND AS FREE OF KINKS. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION INVESTIGATION CONCLUSIONS:A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS FOR USE STATE,"VISUAL/Y INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE''."DEVICE MAY NOT BE USED PRIOR TO TRAINING BY MANUFACTURER"."SLOWLY INTRODUCE NEEDLE INTO ACCESSORY CHANNEL OF ENDOSCOPE AND ADVANCE IN SHORT INCREMENTS. ENSURE NEEDLE IS COMPLETELY RETRACTED AND LOCKED IN PLACE NOTE: BENDS OR KINKS IN NEEDLE CAUSED BY IMPROPER INTRODUCTION MAY RESULT IN THE INABILITY TO DEPLOY FIDUCIALS"."THE NEEDLE TIP CAN SLOWLY BE RETRACTED AND ADVANCED INTO ANOTHER SITE TO PLACE ADDITIONAL FIDUCIALS AS NEEDED." IT IS POSSIBLE THAT IF THE NEEDLE IS AGAINST OR INSIDE OF A HARD MASS WHILE THE USER APPLIES FORCE AND MANIPULATES THE DIRECTIONAL CONTROLS OF THE ENDOSCOPE THIS COULD CONTRIBUTE TO SEVERE BENDING OF THE NEEDLE NEAR THE DISTAL END. THIS CONTRIBUTE TO ADVANCEMENT AND/OR RETRACTION DIFFICULTIES. KINKS IN THE NEEDLE CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING PRODUCT HANDLING/PREPARATION. THE INSTRUCTIONS FOR USE STATE, "ATTACH DEVICE TO ACCESSORY CHANNEL PORT." THE INSTRUCTIONS FOR USE ALSO CAUTIONS THE USER THAT, "FAILURE TO ATTACH DEVICE PRIOR TO NEEDLE ADJUSTMENT OR EXTENSION MAY RESULT IN DAMAGE TO ENDOSCOPE".ATTACHING THE NEEDLE TO THE ENDOSCOPE WILL ALSO AID IN PRESERVING THE DEVICE INTEGRITY AND FUNCTION. PRIOR TO DISTRIBUTION, ALL ECHOTIP ULTRA FIDUCIAL NEEDLES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH FIDUCIAL PLACEMENT, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. AN ENDOSCOPIC ULTRASOUND WITH FIDUCIAL PLACEMENT WAS BEING PERFORMED BY GOING THROUGH THE PATIENT'S STOMACH WALL. THE ECHOTIP ULTRA FIDUCIAL NEEDLE WAS IN THE LESION AND A CLICKING SOUND WAS HEARD WHEN ATTEMPTING TO DEPLOY THE FIRST FIDUCIAL; HOWEVER, THE FIDUCIAL DID NOT DEPLOY. THEY TRIED TO DEPLOY BUT NONE WOULD [DEPLOY]. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RECEIVED FOR INVESTIGATION ON 07/07/15. UPON EXAMINATION OF THE DEVICE, A SEVERE BEND WAS FOUND IN THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483756 ECHOTIP ULTRA FIDUCIAL NEEDLE NEU WILSON-COOK MEDICAL INC. W3449638

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS LINEAR ARRAY ENDOSCOPE (UNK MODEL)