BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRASOUND NEEDLE

    MDR report key: 3063521 · Received April 12, 2013

    Report

    Report Number
    1037905-2013-00143
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 14, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE NEEDLE HAD A CURVE IN THE DISTAL END. THE NEEDLE WOULD EXTEND AND RETRACT. WITH THE NEEDLE EXTENDED THERE WAS A BEND IN THE SHEATH APPROXIMATELY 8.5CM FROM THE HUB. WHEN THE NEEDLE WAS ADVANCED INTO AN OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN A RETROFLEXED POSITION TO STIMULATE A WORST CASE SITUATION THE NEEDLE WOULD EXTEND AND RETRACT. THE CURVE IN THE NEEDLE AND THE BEND IN THE SHEATH COULD HAVE CONTRIBUTED TO THE DIFFICULTY ADVANCING. 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. PRIOR TO DISTRIBUTION, ALL COOK DEVICES 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 AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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 FINE NEEDLE ASPIRATION (FNA), THE PHYSICIAN USED A COOK ECHOTIP ULTRASOUND NEEDLE. THE NEEDLE WOULD NOT EXIT THE SHEATH. ANOTHER ECHOTIP ULTRASOUND NEEDLE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. OUR LABORATORY EVALUATION CONFIRMED THE COOK ECHOTIP ULTRASOUND NEEDLE WAS BENT AND IS CONSIDERED A REPORTABLE OCCURRENCE. 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
    159102 ECHOTIP ULTRASOUND NEEDLE FCG WILSON-COOK MEDICAL INC W3208378

    Patients

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