BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUIBREGTSE SINGLE LUMEN NEEDLE KNIFE

    MDR report key: 1910981 · Received November 23, 2010

    Report

    Report Number
    1037905-2010-00623
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K972674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE BROKEN AND DETACHED SECTION OF THE NEEDLE SEPARATE FROM THE DEVICE. THE DETACHED SECTION OF THE NEEDLE MEASURES 4MM IN LENGTH AND 0.0075 INCHES IN DIAMETER. THERE IS EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE NEEDLE WAS NOTED AT THE BREAK). NO SECTION OF THE DEVICE IS MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED 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 PRODUCTS 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 REPORTS IS RARE. 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, ENDOSCOPE POSITION 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 AND DETACHMENT 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. THIS 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 MFR'S INSTRUCTIONS. THIS 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 KNIVES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION 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: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION TAKEN AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY HUIBREGTSE SINGLE LUMEN NEEDLE KNIFE. DURING AN APPLICATION OF CAUTERY, THE NEEDLE BROKE AND DETACHED FROM THE DISTAL END OF THE DEVICE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY REMOVE THE DETACHED SECTION OF THE NEEDLE. (NOTE: THE DETACHED SECTION OF THE NEEDLE IS ESTIMATED TO BE 4MM IN LENGTH AND 0.0075 INCHES IN DIAMETER.) 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 HUIBREGTSE SINGLE LUMEN NEEDLE KNIFE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W2899904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ERBE ELECTROSURGICAL GENERATOR| OLYMPUS TJF-160V ENDOSCOPE