BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP

    MDR report key: 3050552 · Received March 12, 2013

    Report

    Report Number
    1037905-2013-00096
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DRIVE WIRE HAS SEPARATED INSIDE THE HANDLE. THE DEVICE WAS ADVANCED INTO OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN A RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. USING A HEMOSTAT TO GRASP THE DRIVE WIRE, THE CLIP DID SUCCESSFULLY DEPLOY ON SIMULATED TISSUE. A SLIGHT CATCH OR INCREASE IN RESISTANCE WAS OBSERVED IN THE MOVEMENT OF THE DRIVE WIRE ONCE THE CLIP WAS PULLED HALFWAY INTO THE HOUSING PRIOR TO DEPLOYMENT. THE DRIVE WIRE ASSEMBLY WAS REMOVED AND A VISUAL EXAMINATION DETERMINED THAT THE DEVICE WAS MANUFACTURED PER THE APPROPRIATE MANUFACTURING SPECIFICATIONS. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED AS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED DUE TO THE CONDITION OF THE RETURNED PRODUCT AND BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. IN ADDITION, DUE TO A VARIETY OF CLINICAL CONDITIONS, SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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 THE PROCEDURE, A TOTAL OF THREE (3) COOK DISPOSABLE HEMOSTASIS CLIPS WERE USED. THE FIRST CLIP BROKE (MDR 1037905-2013-00096) AND THE SECOND CLIP WOULD NOT DEPLOY (MDR 1037905-2013-00097). THE THIRD CLIP WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. OUR LABORATORY EVAL OF BOTH DEVICES CONFIRMED THE DRIVE WIRE HAS DISCONNECTED FROM THE HANDLE. THIS HAS BEEN ESTABLISHED AS A REPORTABLE OCCURRENCE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFO REGARDING PT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADD'L MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFO ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104771 CLIP MND WILSON-COOK MEDICAL, INC. W3223704

    Patients

    Seq Age Sex Outcome Treatment
    1