BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 4182127 · Received July 15, 2014

    Report

    Report Number
    1037905-2014-00288
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. DIFFICULTY WITH ELECTROSURGICAL CURRENT APPLICATION COULD HAVE OCCURRED IF ANY CORD CONNECTIONS WERE NOT SECURE. THESE CONNECTIONS INCLUDE ELECTROSURGICAL UNIT TO ACTIVE CORD AND ACTIVE CORD TO SPHINCTEROTOME. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "WITH ELECTROSURGICAL UNIT OFF, PREPARE EQUIPMENT. ACTIVE CORD FITTINGS SHOULD FIT SNUGLY INTO BOTH DEVICE HANDLE AND THE ELECTROSURGICAL UNIT." THIS VERIFICATION ACTIVITY WILL ENSURE THE EQUIPMENT IS PREPARED TO PROVIDE THE ELECTROSURGICAL CURRENT THE SPHINCTEROTOME NEEDS FOR DEVICE USAGE. INSPECTION REFERRED TO IN CURRENT CONTROLS INCLUDES FINAL QUALITY CONTROL. THE ELECTRICAL PIN IN THE HANDLE IS CONNECTED TO AN ACTIVE CORD TO VERIFY A SECURE CONNECTION. AN OHM METER IS USED TO VERIFY CONTINUITY BETWEEN THE CUTTING WIRE AND ELECTRICAL PIN. PRIOR TO DISTRIBUTION, ALL D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE WAS USED. THE DEVICE ALLOWED COAGULATION/BURNING BUT DID NOT CUT TISSUE. THE PHYSICIAN ELECTED TO OPEN AND USE A FUSION OMNI TOME TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. 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
    412506 D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3323837

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF Q180V ENDOSCOPE, ERBE ICC 200,| ACTIVE CORD