BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME

    MDR report key: 1852414 · Received September 29, 2010

    Report

    Report Number
    1037905-2010-00491
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 3, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE BLACK OUTER COATING OF THE WIRE GUIDE TIP HAS SEPARATED COMPLETELY FROM THE WIRE GUIDE. THE DETACHED SECTION OF THE WIRE GUIDE COATING WAS NOT INCLUDED IN THE RETURN. THE COIL SPRING CONNECTION AT THE VERY DISTAL END OF THE WIRE GUIDE REMAINS SECURE. A SEVERE KINK WAS ALSO OBSERVED IN THE BODY OF THE WIRE GUIDE APPROX 277CM FROM THE PROXIMAL END. A PRODUCT 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 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. IF THE WIRE GUIDE RECEIVED EXCESSIVE PRESSURE, PERHAPS IN RESPONSE TO RESISTANCE DUE TO A SEVERE STRICTURE, THIS COULD HAVE CONTRIBUTED TO THE SEVERE KINK AND WIRE GUIDE COATING DAMAGE OBSERVED. THE INSTRUCTIONS FOR USE ADVISE THE USER TO ADVANCE THE PRODUCT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN PRESERVATION OF THE PRODUCT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO FLUSH THE INJECTOR PORT WITH STERILE WATER. THE INSTRUCTIONS FOR USE INDICATE THE WIRE GUIDE SHOULD BE KEPT WET FOR BEST RESULTS. IF THE ENDOSCOPE USED WITH THIS WIRE GUIDE CONTAINED A ROUGH EDGE OR BURR, THIS COULD HAVE CONTRIBUTED TO THE WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL WIRE GUIDES INCLUDED IN THE D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL 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 WARRANTED 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 D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME, WHICH IS LOADED WITH A COATED WIRE GUIDE. DURING USE, THE SPHINCTEROTOME WAS REMOVED AND THE WIRE GUIDE WAS LEFT IN PLACE. DURING REMOVAL OF THE SPHINCTEROTOME FROM THE WIRE GUIDE, THE BLACK COATING OF THE WIRE GUIDE TIP DETACHED INSIDE THE DUCT. THE DETACHED WIRE GUIDE COATING WAS REMOVED FROM THE DUCT WHEN AN EXTRACTION BALLOON WAS USED TO SWEEP THE DUCT. THE WIRE GUIDE COATING WAS LEFT IN THE SMALL INTESTINE TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. NO ADDITIONAL 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 D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCE KNS COOK ENDOSCOPY W2821132

    Patients

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