BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 3880086 · Received April 3, 2014

    Report

    Report Number
    1037905-2014-00118
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 7, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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, ALL COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE 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 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 ENDOSCOPY PROCEDURE, A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME WAS USED. THE PHYSICIAN ADVANCED THE SPHINCTEROTOME DOWN THE ENDOSCOPE. WHILE CANNULATING THE AMPULLA THE WIRE GUIDE APPEARED TO CATCH IN THE PATIENTS MUCOSA THEN FREED ITSELF WITH NO TRAUMA TO THE PATIENT. THE PHYSICIAN REMOVED THE SPHINCTEROTOME OFF THE WIRE GUIDE. A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING (FS-8.5-12-15-A) WAS ADVANCED OVER THE WIRE GUIDE, BUT THEY WERE UNABLE TO CANNULATE THE DUCT AS THE BALLOON WAS BUCKLING. AFTER REMOVING THE BALLOON AND WIRE GUIDE IT APPEARED THAT THE WIRE HAD DE-GLOVED, WHICH PREVENTED THEM TO CANNULATE INTO THE DUCT. 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
    202236 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES KNS WILSON-COOK MEDICAL INC W3330943

    Patients

    Seq Age Sex Outcome Treatment
    1 SIZING (FS-8.5-12-15-A)| COOK FUSION EXTRACTION BALLOON WITH MULTIPLE| OLYMPUS TJF 240 ENDOSCOPE