BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 3853136 · Received April 2, 2014

    Report

    Report Number
    1037905-2014-00113
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 4, 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. IF ADDITIONAL PRESSURE IS APPLIED TO THE WIRE GUIDE AND/OR ACCESSORY DEVICE(S) WHILE MOVING THE WIRE GUIDE INSIDE THE ACCESSORY DEVICE(S), THIS COULD CONTRIBUTE TO WIRE GUIDE DAMAGE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT NOTES FOR BEST RESULTS, WIRE GUIDE SHOULD BE KEPT WET. PRIOR TO DISTRIBUTION, ALL COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST 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. WHEN STRIPPING THE SPHINCTEROTOME THE WIRE GUIDE STARTED TO UNWIND AND THEN BROKE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE THE PATIENT. 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
    200196 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3330944

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF 260 ENDOSCOPE