BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 1950117 · Received December 8, 2010

    Report

    Report Number
    1037905-2010-00699
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF NEEDLE BREAKAGE. UPON VISUAL EXAMINATION, WE CONFIRMED THE 19-GAUGE NEEDLE HAS BROKEN AND DETACHED FROM THE NEEDLE DEVICE NEAR THE DISTAL END. THE BROKEN AND DETACHED SECTION OF THE NEEDLE IS APPROXIMATELY 2CM IN LENGTH. THE AREA OF NEEDLE BREAKAGE WAS VIEWED UNDER MAGNIFICATION. THE AREA HAS BEEN FLATTENED AND IS BENT TOGETHER. THE NEEDLE MATERIAL IN THE BROKEN AREA IS EXTENDING OUTWARD SLIGHTLY, CREATING A ROUGH EDGE. THE OUTER SHEATH OF THE NEEDLE EXHIBITS A SEVERE KINK LOCATED APPROXIMATELY 2CM FROM THE DISTAL END OF THE DEVICE. THE LOCATION OF THE SEVERE KINK IS SUCH THAT IF THE NEEDLE IS IN THE RETRACTED POSITION, THIS IS DIRECTLY IN LINE WITH THE AREA OF THE NEEDLE BREAKAGE. THE APPEARANCE OF THE OUTER SHEATH AND DAMAGED NEEDLE SUGGEST THAT WHILE THE NEEDLE WAS IN THE RETRACTED POSITION, AN OUTSIDE FORCE FROM ANOTHER DEVICE CAUSED THE OUTER CATHETER TO KINK SEVERELY AND THE NEEDLE SHAFT TO COLLAPSE - EVENTUALLY RESULTING IN BREAKAGE AND DETACHMENT OF THE NEEDLE. THE NEEDLE DEVICE WAS RETURNED WITH THE INNER STYLET PULLED BACK APPROXIMATELY 3CM. THE STYLET WAS FULLY REMOVED FROM THE NEEDLE AND DAMAGE TO THE SHAFT OF THE STYLET WAS NOT OBSERVED. BASED ON THE STYLET POSITION UPON RETURN AS WELL AS FINDING NO EVIDENCE OF DAMAGE, WE BELIEVE THE STYLET WAS NOT FULLY IN PLACE WHEN THE DAMAGE TO THE NEEDLE OCCURRED AT 2CM FROM THE DISTAL END. A PRODUCT SPECIFIC DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OCCURRENCE WAS NOT OBSERVED. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: THE CONDITION OF THE RETURNED DEVICE SUGGESTS AN OUTSIDE FORCE FROM ANOTHER DEVICE CAUSED THE DAMAGE OBSERVED. IF THE ELEVATOR OF THE ENDOSCOPE WAS USED TO PLACE THE NEEDLE IN A SEVERE ANGLE, THIS COULD HAVE CAUSED THE NEEDLE SHAFT TO COLLAPSE AND THE OUTER CATHETER TO KINK. APPLYING PRESSURE TO THE HANDLE WITH THE NEEDLE IN THE DAMAGED CONDITION, PERHAPS IN AN ATTEMPT TO EXTEND THE NEEDLE, COULD HAVE LED TO FULL BREAKAGE AND DETACHMENT OF THE NEEDLE. PRIOR TO DISTRIBUTION, ALL ECHO TIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION INCLUDES VERIFYING THE PRODUCT IS FREE OF KINKS AND BENDS. THE FUNCTIONAL TEST INCLUDES EXTENDING AND RETRACTING THE NEEDLE TO ENSURE PROPER NEEDLE FUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON OUR INVESTIGATION OF THE RETURNED DEVICE, THIS MAY BE RELATED TO OPERATIONAL CONTEXT. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. 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 AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ENDOSCOPY ECHO TIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE NEEDLE WAS ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. RESISTANCE IN NEEDLE EXTENSION FROM THE OUTER CATHETER WAS ENCOUNTERED DURING USE. UPON REMOVING THE NEEDLE FROM THE PT AND ENDOSCOPE, THE USER NOTICED THE NEEDLE TIP HAD BROKEN INSIDE THE OUTER CATHETER. WHILE THE DEVICE WAS OUTSIDE THE PT AND ENDOSCOPE, THE NEEDLE WAS EXTENDED FROM THE OUTER CATHETER. AT THIS TIME, THE BROKEN NEEDLE FULLY DETACHED FROM THE DEVICE. ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L 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
    1 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG, SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY FCG COOK ENDOSCOPY W2611491

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)