BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 4241326 · Received September 4, 2014

    Report

    Report Number
    1037905-2014-00344
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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 PRODUCT DETERMINED THAT THE DISTAL END OF THE NEEDLE HAD A BEND. THE DISTAL 6 CM OF THE NEEDLE IS NOT STRAIGHT. THE DIMPLED AREA OF THE NEEDLE IS IN THE PROPER LOCATION. THE DIMPLE PATTERN HAS THE CORRECT LENGTH AND IS WITHIN THE APPROPRIATE MANUFACTURING SPECIFICATION. THE DIAMETER OF FIVE DIMPLES WERE MEASURED AT RANDOM ON THE DEVICE AND ALL MEASURED WITHIN APPROPRIATE MANUFACTURING SPECIFICATION. THE AMOUNT OF DIMPLES WERE WITHIN APPROPRIATE MANUFACTURING SPECIFICATION. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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, "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

    THIS REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS REPORT ON (B)(6) 2014, THAT DETERMINED THE NEEDLE WAS BENT. DURING THE PROCEDURE, A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE WAS USED. THE NEEDLE COULD NOT BE SEEN UNDER ULTRASOUND. ANOTHER NEEDLE WAS USED FROM A DIFFERENT LOT, THAT COULD BE SEEN UNDER ULTRASOUND AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE AND ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE AND ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542346 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG, BIOPSY NEEDLE KIT FCG WILSON-COOK MEDICAL INC W3414343

    Patients

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