BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 4093229 · Received August 21, 2014

    Report

    Report Number
    1037905-2014-00327
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. APPROXIMATELY 6.7 CM FROM THE DISTAL TIP OF THE DEVICE, THE COATING IS PEELED BACK ON THE CORE WIRE OF THE WIRE GUIDE EXPOSING 4.8 CM OF EXPOSED WIRE. ADDITIONALLY, NEAR THE 25 CM MARK THE COATING OF THE WIRE GUIDE IS PEELED BACK ON THE CORE WIRE EXPOSING A SECTION FOR APPROXIMATELY 12.5 CM. THE PEELED COATING IN BOTH SECTIONS IS ACCORDIONED ON THE WIRE GUIDE BUT NO PORTION OF THE DEVICE IS FOUND TO BE MISSING. 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 PATIENT 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. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT NOTES FOR BEST RESULTS, WIRE GUIDE SHOULD BE KEPT WET. ALSO, USE OF THIS WIRE GUIDE WITH METAL TIP ERCP DEVICES MAY RESULT IN DAMAGE TO THE EXTERNAL COATING AND/OR TIP OF THE WIRE GUIDE. PRIOR TO DISTRIBUTION, A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. APPROXIMATELY 6-7 CM FROM THE TIP OF THE WIRE GUIDE, THE PROTECTIVE COATING CAME OFF THE WIRE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE OF THE PATIENT OR ENDOSCOPE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504549 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3335084

    Patients

    Seq Age Sex Outcome Treatment
    1 FUJINON 4.2MM ENDOSCOPE: MODEL #UNK| FUSION WIRE LOCK: FS-WL-O-S