BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE

    MDR report key: 2780771 · Received October 5, 2012

    Report

    Report Number
    1037905-2012-00558
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K972674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH A SECTION OF THE NEEDLE BROKEN. THE DETACHED SECTION OF THE NEEDLE WAS INCLUDED IN THE RETURN. WITH THE BLACK STOPPER BLOCK FLUSH WITH THE 7TH MARK ON THE HANDLE STEM, THE NEEDLE DID EXTEND JUST TO THE EXTERNAL TIP OF THE CATHETER. THE RETURNED DETACHED SECTION WAS MEASURED AND WAS OBSERVED TO BE BENT AT THE SECTION WHERE THE BREAK OCCURRED. WE CAN CONCLUDE THAT NO SECTION OF THE DEVICE IS MISSING. THERE IS EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE NEEDLE WAS NOTED AT THE BREAK ON THE DETACHED SECTION AND THE REMAINING ATTACHED NEEDLE). 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 PT ANATOMY 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. NEEDLE KNIFE BREAKAGE NEAR THE DISTAL END CAN OCCUR IF THE PRODUCT EXPERIENCES LIMITED MOVEMENT OF THE NEEDLE KNIFE DURING ELECTROCAUTERY APPLICATION. THE INSTRUCTIONS STATE THAT IT IS ESSENTIAL TO MOVE THE NEEDLE KNIFE WHILE APPLYING CURRENT. MAINTAINING THE NEEDLE KNIFE IN ONE POSITION CAN RESULT IN BREAKAGE OF THE NEEDLE KNIFE. NEEDLE KNIFE BREAKAGE NEAR THE DISTAL END CAN OCCUR IF THE DEVICE IS USED WITH EXCESSIVE CAUTERY SETTINGS. THE INSTRUCTIONS FOR USE DIRECT THE USER TO VERIFY THE DESIRED SETTINGS BY FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS. NEEDLE KNIFE BREAKAGE NEAR THE DISTAL END CAN ALSO OCCUR IF THE NEEDLE MAKES CONTACT WITH THE DISTAL END OF THE ENDOSCOPE DURING A CAUTERY APPLICATION. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE CAUTION THAT THE NEEDLE KNIFE MUST FULLY EXIT THE ENDOSCOPE WHEN APPLYING CURRENT. PRIOR TO DISTRIBUTION, ALL HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST 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

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE WAS USED. THE NEEDLE KNIFE WAS INSERTED TO CUT THE PAPILLA. THE NEEDLE WAS SLOWLY MOVED TOWARD THE PAPILLA DURING CUTTING. AFTER APPLYING CURRENT 2-3 TIMES, THE EXPOSED CUTTING WIRE [NEEDLE TIP] WAS BROKEN AND LEFT [LOCATED] INSIDE THE PTS BODY. TO FINISH THE PROCEDURE, THEY SWITCHED TO NEEDLE KNIFE MADE BY ANOTHER COMPANY TO DO THE PAPILLOTOMY. PART OF CUTTING WIRE WAS BROKEN AND LOCATED INSIDE THE PT'S BODY. A SNARE WAS USED TO RETRIEVE THE BROKEN PART. 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
    1 HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W3041920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS TFJ260V ENDOSCOPE