BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA FIDUCIAL NEEDLE

    MDR report key: 4213423 · Received October 23, 2014

    Report

    Report Number
    1037905-2014-00416
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    NEU
    PMA / PMN Number
    K141356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM HANDLE BREAKAGE AS REPORTED. HOWEVER, WE FOUND A PORTION OF THE DISTAL END MISSING. THE NEEDLE MEASURED 167.1 CM FROM THE HUB TO THE DISTAL TIP. THEREFORE, APPROXIMATELY 4 CM OF THE DISTAL TIP IS MISSING. A VISUAL INSPECTION DETERMINED THAT THE TIP OF THE NEEDLE BROKE OFF APPROXIMATELY 1 MM DISTAL OF THE BEGINNING OF THE SLOT THAT HOLDS THE FIDUCIALS. THERE ARE MULTIPLE BENDS AND KINKS ALONG THE LENGTH OF THE NEEDLE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB 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 OR DISEASE STATED, 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 CONTAIN THE FOLLOWING STATEMENTS: "NEEDLE MUST BE RETRACTED INTO SHEATH AND THUMBSCREW ON SAFETY RING MUST BE LOCKED TO HOLD NEEDLE IN PLACE PRIOR TO INTRODUCTION, ADVANCEMENT OR WITHDRAWAL OF DEVICE". "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". "DEVICE MAY NOT BE USED PRIOR TO TRAINING BY MFR". "SLOW INTRODUCE NEEDLE INTO ACCESSORY CHANNEL OF ENDOSCOPE AND ADVANCE IN SHORT INCREMENTS. ENSURE NEEDLE IS COMPLETELY RETRACTED AND LOCKED IN PLACE. NOTE: BENDS OR KINKS IN NEEDLE CAUSED BY IMPROPER INTRODUCTION MAY RESULT IN THE INABILITY TO DEPLOY FIDUCIALS". "THE NEEDLE TIP CAN SLOWLY BE RETRACTED AND ADVANCED INTO ANOTHER SITE TO PLACE ADDITIONAL FIDUCIALS AS NEEDED". "ATTACH DEVICE TO ACCESSORY CHANNEL PORT," THE INSTRUCTIONS FOR USE ALSO CAUTIONS THE USER THAT, "FAILURE TO ATTACH DEVICE PRIOR TO NEEDLE ADJUSTMENT OR EXTENSION MAY RESULT IN DAMAGE TO ENDOSCOPE". ATTACHING THE NEEDLE TO THE ENDOSCOPE WILL ALSO AID IN PRESERVING THE DEVICE INTEGRITY AND FUNCTION. IT IS POSSIBLE THAT IF NEEDLE IS A 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. THIS CONTRIBUTE TO ADVANCEMENT AND/OR RETRACTION DIFFICULTIES. KINKS IN THE NEEDLE CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING PRODUCT HANDLING/PREPARATION. PRIOR TO DISTRIBUTION, ALL ECHOTIP ULTRA FIDUCIAL 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. 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) PROCEDURE, A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE WAS USED. THE DOCTOR WANTED TO PLACE THE FIDUCIAL IN THE PANCREATIC MASS THROUGH THE STOMACH WALL. THE DOCTOR HAD MUCH DIFFICULTY PUNCTURING THROUGH THE WALL. THE HANDLE THEN BROKE AND WAS REMOVED FROM THE PT'S BODY WITH NO DEVICE PORTION LEFT BEHIND. THE INFO PROVIDED INDICATED THAT NO SECTION OF THE DEVICE DETACHED INSIDE THE PT. ANOTHER OF THE SAME DEVICE WAS USED SUCCESSFULLY, PLACING 2 FIDUCIALS. THE DEVICE WAS RECEIVED AT COOK FOR EVAL ON (B)(4) 2014. OUR LABORATORY EVAL CONFIRMED THE HANDLE OF THE DEVICE WAS NOT BROKEN. HOWEVER, APPROXIMATELY 4 CM OF THE NEEDLE IS BROKEN AT THE DISTAL END OF THE DEVICE. THE BROKEN PORTION OF THE NEEDLE WAS NOT INCLUDED IN THE RETURN. INFO REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE MISSING SECTION IS UNK AT THIS TIME. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT DETACH INSIDE THE PT'S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING IN OUR LABORATORY EVAL IS UNK. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675931 ECHOTIP ULTRA FIDUCIAL NEEDLE NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT NEU WILSON-COOK MEDICAL INC. W3447098

    Patients

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