BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 4041059 · Received August 13, 2014

    Report

    Report Number
    1037905-2014-00322
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL END OF THE NEEDLE IS BENT. THE DEVICE WAS RETURNED WITH A KINK IN THE SHEATH APPROXIMATELY 4 CM FROM THE DISTAL END OF THE HANDLE. APPROXIMATELY 4 CM FROM THE DISTAL END IS A BEND IN THE NEEDLE. FIVE DIMPLES WERE MEASURED AND WERE ALL WITHIN MANUFACTURER SPECIFICATIONS. THE LENGTH OF THE DIMPLED AREA WAS MEASURED AND WAS WITHIN MANUFACTURER SPECIFICATION. THE DISTANCE OF THE DIMPLES FROM THE DISTAL END AND NUMBER OF COLUMNS WERE WITHIN MANUFACTURING SPECIFICATION. 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 OF 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, "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". IT IS POSSIBLE THAT IF NEEDLE IS AGAINST OR INSIDE 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. DIFFICULTY IN NEEDLE VISUALIZATION CAN OCCUR IF THE ULTRASOUND EQUIPMENT IS IN NEED OF REPAIR OR ADJUSTMENT. ALSO, IF THE NEEDLE IS OUTSIDE OF THE PLANE OF VIEW OF THE ULTRASOUND DURING USE, DIFFICULTY IN NEEDLE VISUALIZATION CAN BE EXPERIENCED. IT IS POSSIBLE FOR THE NEEDLE TO CURVE OUTSIDE OF THE ULTRASOUND PLANE DURING INSERTION INTO THE TARGETED TISSUE. THE INSTRUCTIONS FOR USE GIVE STEP BY STEP INSTRUCTIONS FOR ADJUSTING THE LENGTH OF THE EXTENDED NEEDLE. THE LENGTH OF THE EXTENDED NEEDLE MAY BE ADJUSTED ZERO TO 8 CM. THE INSTRUCTIONS FOR USE STATE, "WITH ULTRASOUND ENDOSCOPE AND DEVICE STRAIGHT, ADJUST NEEDLE TO DESIRED LENGTH BY LOOSENING THUMBSCREW ON SAFETY RING, AND ADVANCING IT UNTIL DESIRED REFERENCE MARK FOR NEEDLE ADVANCEMENT APPEARS IN THE WINDOW OF THE SAFETY RING. TIGHTEN THUMBSCREW TO LOCK SAFETY RING IN PLACE." FAILURE TO FOLLOW THE INSTRUCTIONS FOR ADJUSTING THE NEEDLE LENGTH COULD RESULT IN EXCESSIVE NEEDLE LENGTH FOR THE PROCEDURE. THE INSTRUCTIONS FOR USE STATE, "NOTE: NUMBER IN SAFETY LOCK RING WINDOW INDICATES EXTENSION OF THE NEEDLE IN CENTIMETERS." PRIOR TO DISTRIBUTION, ALL ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 ULTRASONOGRAPHY (EUS), A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE WAS USED. THE NEEDLE COULD NOT BE SEEN UNDER ULTRASOUND. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADD'L 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
    483157 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG, BIOPSY NEEDLE KIT FCG WILSON-COOK MEDICAL INC W3431253

    Patients

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