BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA

    MDR report key: 1001235 · Received February 22, 2008

    Report

    Report Number
    1037905-2008-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    November 27, 2007
    Report Date
    January 25, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORT OF NEEDLE SLIPPAGE. THE THUMBSCREWS ON THE NEEDLE SAFETY RING AND SLIDING SHEATH ADJUSTER TIGHTEN APPROPRIATELY, PREVENTING THE NEEDLE AND SHEATH FROM MOVING BEYOND THE SET EXTENSION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION OF NEEDLE SLIPPAGE WAS NOT OBSERVED DURING OUR ANALYSIS OF THE RETURNED PRODUCT. THE NEEDLE DOES NOT EXTEND AND RETRACT WITH HANDLE MOVEMENT BECAUSE THE NEEDLE EXHIBITS SEVERAL KINKS NEAR THE HANDLE. ONE SEVERE KINK WAS OBSERVED IN THE NEEDLE APPROXIMATELY 27CM FROM THE HANDLE. THE CONDITION OF THE DEVICE (I.E. KINKS IN THE NEEDLE) SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED TO THE DEVICE DURING USE AND/OR GENERAL HANDLING. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. IN THE PAST TWELVE MONTHS, THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSIONS: WE WERE UNABLE TO CONFIRM THE REPORTED OCCURRENCE BECAUSE THE THUMBSCREWS ON THE SAFETY RING AND SHEATH ADJUSTER FUNCTIONED AS INTENDED DURING OUR EVALUATION AND A PRODUCT DISCREPANCY THAT COULD HAVE CONTRIBUTED TO SLIPPAGE OF THE NEEDLE WAS NOT OBSERVED WITH THE DEVICE. THE INFO PROVIDED INDICATED THAT NEEDLE PENETRATION OF THE TARGETED SITE WAS DIFFICULT. OUR EVALUATION OF THE RETURNED DEVICE SUGGESTS THE DEVICE RECEIVED EXCESSIVE PRESSURE DURING USE. APPLYING EXCESSIVE PRESSURE TO THE HANDLE DURING NEEDLE EXTENSION IS THE MOST LIKELY CAUSE FOR SLIPPAGE OF THE NEEDLE. IT IS POSSIBLE THE THUMBSCREW ON THE SAFETY RING SECTION OF THE HANDLE WAS NOT TIGHTENED BY THE END USER ENOUGH TO WITHSTAND FORCEFUL ADVANCEMENT OF THE NEEDLE. THIS COULD HAVE CONTRIBUTED TO SLIPPAGE OF THE SAFETY RING DURING NEEDLE EXTENSION. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADJUST THE NEEDLE TO THE DESIRED LENGTH BY LOOSENING THE THUMBSCREW ON THE SAFETY RING AND ADVANCING IT UNTIL THE DESIRED REFERENCE MARK FOR NEEDLE ADVANCEMENT APPEARS IN THE WINDOW OF THE SAFETY RING. THE INSTRUCTIONS THEN DIRECT THE USER TO TIGHTEN THE THUMBSCREW TO LOCK THE SAFETY RING IN PLACE. SEVERE KINKS IN THE NEEDLE CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE. IF THE NEEDLE EXPERIENCES MULTIPLE PASSES TO OBTAIN MULTIPLE SAMPLES, OR IF THE MASS TO SAMPLE IS VERY HARD, A BEND IN THE NEEDLE CAN OCCUR. PRIOR TO DISTRIBUTION, THE THUMBSCREW IS TIGHTENED AND LOOSENED AT VARIOUS STAGES DURING THE INSPECTION STAGE. ALL ENDOSCOPIC ULTRASOUND NEEDLES ARE SUBJECTED TO THIS TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE THUMBSCREWS ON THE SAFETY RING AND SHEATH ADJUSTER FUNCTIONED AS INTENDED. THE REPORTED OBSERVATION REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A FINE NEEDLE ASPIRATION (FNA) TARGETED IN THE PANCREAS, THE PHYSICIAN USED A COOK ENDOSCOPY ECHO TIP ULTRA ULTRASOUND NEEDLE. THE NEEDLE WAS EXTENDED TO PERFORM THE ASPIRATION. HOWEVER, THE NEEDLE PROTRUDED MORE THAN REQUIRED BECAUSE THE THUMBSCREW OF THE SAFETY RING WAS LOOSE ON THE HANDLE. THE PROCEDURE WAS CONTINUED BY USING ANOTHER ECHOTIP ULTRA ULTRASOUND NEEDLE. THE PT HAD NO COMPLICATIONS DUE TO THIS OCCURRENCE. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOTIP ULTRA FCG SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY FCG COOK ENDOSCOPY NA W2405141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR