BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7146082 · Received December 26, 2017

    Report

    Report Number
    1037905-2017-00786
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 26, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    UDI-DI
    00827002315211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    K171596. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THE REPORT. THE DEVICE WAS RETURNED WITH THE STYLET WIRE IN THE DEVICE AND THE PRE-PACKAGED SYRINGE. THE NEEDLE ADJUSTER WAS PLACED ON "8" AND THE SHEATH ADJUSTER WAS PLACED ON "5", AND THE HANDLE WAS THEN MANIPULATED. THE NEEDLE WOULD ADVANCE AND RETRACT SMOOTHLY WITHOUT ANY DIFFICULTY. THE SHEATH WAS BENT FROM 7.2 CM - 10.1 CM FROM THE DISTAL END OF THE HANDLE WHEN THE NEEDLE WAS FULLY ADVANCED OUTSIDE THE DISTAL END OF THE SHEATH. THE BEND NEAR THE BASE OF THE HANDLE COULD HAVE OCCURRED IF THE USER DID NOT ATTACH THE DEVICE TO THE BIOPSY PORT OF THE ENDOSCOPE. WHEN THE NEEDLE WAS ADVANCED OUTSIDE THE DISTAL END OF THE SHEATH, A SHARP BEND WAS OBSERVED NEAR THE DISTAL TIP OF THE NEEDLE. THE BEND IN THE ADVANCED NEEDLE WAS AT 5.5 CM FROM THE DISTAL END OF THE SHEATH. A VISUAL INSPECTION UNDER MAGNIFICATION OF THE NEEDLE WAS PERFORMED, AND THE BEVEL OF THE NEEDLE IS UNIFORM AND INTACT. DURING A FUNCTIONAL TEST, THE DEVICE WAS ADVANCED DOWN AN OLYMPUS GF-UCT160P ULTRASONIC ENDOSCOPE. ONCE THE DEVICE WAS ADVANCED OUTSIDE THE DISTAL END OF THE ENDOSCOPE, THE ENDOSCOPE WAS PLACED IN A CURVED POSITION. THE LUER LOCK AT THE DISTAL END OF THE HANDLE WAS ATTACHED TO THE BIOPSY PORT AND THE NEEDLE ADJUSTER WAS PLACED ON "8". THE NEEDLE WOULD ADVANCE AND RETRACT AS INTENDED. 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 CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL PRODUCT HANDLING CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IF EXCESSIVE PRESSURE IS APPLIED TO THE DEVICE, BENDS OR KINKS CAN OCCUR. THE INSTRUCTIONS FOR USE UNDER PRECAUTIONS STATES: "NEEDLE MUST BE FULLY RETRACTED INTO SHEATH AND THUMBSCREW ON SAFETY RING MUST BE LOCKED AT 0 CM TO HOLD NEEDLE IN PLACE PRIOR TO INTRODUCTION, ADVANCEMENT, OR WITHDRAWAL OF DEVICE. FAILURE TO RETRACT NEEDLE MAY RESULT IN DAMAGE TO ENDOSCOPE." 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

    IN PREPARATION FOR A FINE NEEDLE ASPIRATION (FNA) PROCEDURE, THE PHYSICIAN SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. BEFORE THE CASE, THE NURSE CHECKED THE PRODUCT FOR FUNCTIONALITY, AND FOUND THAT THE END OF THE SHEATH CURVED IRREGULARLY [SHEATH BENT]. THEY CHANGED TO ANOTHER NEEDLE [TO FINISH THE PROCEDURE]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12/04/2017, AND IT WAS FOUND TO HAVE A SEVERE BEND IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925772 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG, BIOPSY NEEDLE KIT FCG COOK ENDOSCOPY 00827002315211

    Patients

    Seq Age Sex Outcome Treatment
    1