BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION LOOPTIP WIRE GUIDE

    MDR report key: 2861487 · Received November 28, 2012

    Report

    Report Number
    1037905-2012-00657
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 29, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K033754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE LOOP TIP HAS UNRAVELED AND THE COIL SPRING LOCATED AT THE DISTAL TIP IS MISSING. THE OUTER COATING WAS REMOVED NEAR THE DISTAL TIP. DURING A VISUAL EXAMINATION THERE IS EVIDENCE THAT ADHESIVE HAD BEEN APPLIED TO THE TWISTED SECTION OF THE LOOPED END. THE COIL SPRING LOCATED BEHIND THE DISTAL COIL IS PRESENT. 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 COULD NOT BE DETERMINED BECAUSE THE ACTUAL CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUT LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF 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 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK FUSION LOOPTIP WIRE GUIDE WAS USED. THE MEDICAL FACILITY STATED THAT THE TIP OF THE LOOP TIP FRAYED AFTER ON EXCHANGE WITH THE WIRE GUIDE. THE WIRE GUIDE WAS REMOVED AND ANOTHER WAS ABLE TO BE USED. A SECTION OF THE WIRE GUIDE DID NOT DETACH INSIDE THE ENDOSCOPE OR PATIENT. UPON RETURN OF THE DEVICE FOR EVALUATION, WE CONFIRMED A SMALL SECTION OF THE WIRE GUIDE TIP HAD DETACHED AND WAS NOT INCLUDED IN THE RETURN. INFORMATION REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE MISSING SECTION IS UNKNOWN. 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
    1 FUSION LOOPTIP WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. W3124268

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS THERAPEUTIC ENDOSCOPE (UNK MODEL #)