BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 4110301 · Received September 12, 2014

    Report

    Report Number
    1037905-2014-00348
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Report Date
    August 14, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. TWO POTENTIAL DEVICE HISTORY RECORDS FOR THE SUBASSEMBLY LOT NUMBERS OF THE WIRE GUIDE INVOLVED WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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 EVAL. 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 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: 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. THE WIRE GUIDE FRAYED AFTER ONE EXCHANGE. THE PIECE OF THE FRAYED WIRE DETACHED UPON REMOVAL FROM THE LOCKING DEVICE. NO SECTION OF THE DEVICE DETACHED INSIDE THE PT OR ENDOSCOPE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE AND ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566707 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3435175

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)