BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 5827768 · Received July 27, 2016

    Report

    Report Number
    1037905-2016-00229
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Report Date
    March 15, 2016
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002346939
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER EXEMPTION NUMBER: E2015051. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM. ADDITIONAL LOT NUMBERS: W3674629, W3691405, W3694925, TWENTY (20) UNKNOWN LOT NUMBERS. CONCOMITANT MEDICAL PRODUCTS. COOK FUSION QUATTRO EXTRACTION BALLOON, FS-QEB-A. ERBE ELECTROSURGICAL GENERATOR, UNKNOWN MODEL. ERBE ACTIVE CORD, UNKNOWN MODEL. PLASTIC STENTS, UNKNOWN MAKE OR MODEL. COOK FUSION WIRE LOCK, FS-WL-P-S. PENTAX DUODENOSCOPE, UNKNOWN MODEL. COOK EVOLUTION BILIARY CONTROLLED-RELEASE STENT- FULLY COVERED, EVO-FC-10-11-6. COOK FS-5, UNKNOWN DEVICE (INCOMPLETE REFERENCE PRODUCT NUMBER GIVEN). COOK FUSION QUATTRO EXTRACTION BALLOON, FS-QEB-B. OLYMPUS ELECTROSURGICAL GENERATOR, UNKNOWN MODEL. EXTRACTION BALLOON, UNKNOWN MAKE OR MODEL. METHOD CODE: PROCESS EVALUATION - OF THE TWENTY-FIVE PRODUCTS SAID TO BE INVOLVED, FIVE (5) OF THE PRODUCTS WERE RETURNED TO COOK ENDOSCOPY FOR EVALUATION. ON ALL OF THE FIVE (5) RETURNED PRODUCTS, OUR LABORATORY EVALUATIONS OF THE WIRE GUIDES CONFIRMED THE REPORTS OF COATING DAMAGE TO THE DISTAL END OF THE DEVICE. THE DAMAGE TO THE COATING OF THE RETURNED DEVICES WERE FOUND TO HAVE TAKEN PLACE IN A RANGE OF 15 CM TO 25 CM FROM THE DISTAL TIP OF THE WIRE GUIDE. THE CORE WIRES WERE EXPOSED ON EACH OF THESE DEVICES IN A RANGE OF 0.5 MM TO 11 CM IN LENGTH. NO PORTIONS OF THE COATING ON ANY OF THE RETURNED WIRE GUIDES ARE MISSING. PRODUCT DISCREPANCIES OR ANOMALIES THAT COULD HAVE CONTRIBUTED TO THESE REPORTED OCCURRENCES WERE NOT OBSERVED. A REVIEW OF THE KNOWN SUBASSEMBLIES FOR THESE DEVICES SAID TO BE INVOLVED WERE REVIEWED. TWO (2) OF THESE SUBASSEMBLY REVIEWS FOUND NONCONFORMITIES ON THE CORE WIRE AND COATING OF THE WIRE GUIDE. HOWEVER, A REVIEW OF THE SPECIFICATIONS WAS CONDUCTED AND A 100% VISUAL INSPECTION OF THE COATING ON THE WIRE GUIDE WAS PERFORMED AND INSPECTED FOR ANY DAMAGE OR DEFORMITIES. THIS INSPECTION PROCESS WOULD HAVE REMOVED ANY PRODUCTS PRIOR TO DISTRIBUTION. THEREFORE, A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCTS THAT WERE RELEASED FOR DISTRIBUTION. THE DEVICE HISTORY RECORDS FOR THE KNOWN LOT NUMBERS SAID TO BE INVOLVED WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCTS THAT WERE RELEASED FOR DISTRIBUTION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATIONS COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE RETURNED PRODUCTS SAID TO BE INVOLVED PROHIBITED COMPLETE EVALUATIONS. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATIONS WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCTS. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT "FOR BEST RESULTS, WIRE GUIDE SHOULD BE KEPT WET". THE INSTRUCTIONS FOR USE DESCRIBE THE APPROPRIATE FLUSHING TECHNIQUES FOR USE OF THIS COATED WIRE GUIDE. THESE TECHNIQUES DESCRIBED INCLUDE, FLUSHING THE ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF ACCESSORY DEVICE WITH STERILE WATER BEFORE WIRE GUIDE INSERTION. IF THESE FLUSHING TECHNIQUES ARE NOT FOLLOWED OR INADEQUATE FLUSHING OCCURS, THIS CAN CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL FUSION PRE-LOADED WITH ACROBAT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE KNOWN LOTS SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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

    THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT DURING SEPARATE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIANS USED COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDES. DURING THE PROCEDURES, THE USERS EXPERIENCED COATING DAMAGE TO THE DISTAL END OF THE PRE-LOADED WIRE GUIDES. THERE WERE (B)(6) PATIENTS INVOLVED. OF THESE PATIENTS, THREE (3) WERE REPORTED TO BE MALE. FOUR (4) OF THE PATIENTS HAD PRE-EXISTING BILIARY STONES. THERE WERE NO PATIENT CONSEQUENCES. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES ON VARIOUS DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479811 FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY 10827002346939

    Patients

    Seq Age Sex Outcome Treatment
    1