BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3082575 · Received April 24, 2013

    Report

    Report Number
    1037905-2013-00170
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: THE HANDLE WITH TRIGGER CORD ATTACHED WAS RETURNED. THE BARREL AND BANDS WERE NOT INCLUDED IN THE RETURN. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED DUE TO THE ABSENCE OF THE BARREL AND BANDS. DURING THE LABORATORY EVALUATION, MOVEMENT OF THE HANDLE WHEEL WAS PERFORMED AND FUNCTIONED AS INTENDED. THE TRIGGER CORD WAS DISMANTLED FROM THE MBL ASSEMBLY TO FULLY INVESTIGATION THE INTEGRITY OF THE TRIGGER CORD AND THE BEADS. ALL DEPLOYMENT BEADS WERE PRESENT ON THE TRIGGER CORD AND WERE VERIFIED FOR CORRECT LOCATION. THE BEADS WERE EXAMINED USING MAGNIFICATION AND FOUND TO BE WITHIN THE APPROPRIATE MANUFACTURING SPECIFICATIONS. THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS RESEARCHED TO DETERMINE THE MANUFACTURING DATE OF THE BANDS. WE CAN CONCLUDE FROM THESE DATES THAT THE BANDS WERE WITHIN THE ACCEPTABLE AGE DATE RANGE TO ENSURE THE BANDS MAINTAIN THEIR ELASTICITY PROPERTIES. 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 FOR THIS OBSERVATION COULD NOT BE DETERMINED DUE TO THE CONDITIONS OF THE RETURNED PRODUCT AND BECAUSE THE ACTUAL USE 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 OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, RESTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: "THE USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE." ANOTHER POSSIBLE CONTRIBUTING FACTOR TO BAND DEPLOYMENT DIFFICULTY INCLUDES ALLOWING THE TRIGGER CORD TO BECOME LODGED BETWEEN THE BARREL AND THE DISTAL END OF THE ENDOSCOPE. THIS CAN RESTRICT TRIGGER CORD MOVEMENT AND RESULT IN BAND DEPLOYMENT DIFFICULTY. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE TRIGGER CORD IS NOT PROPERLY SEATED IN THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT THE KNOT MUST BE SEATED INTO THE HOLE OR THE HANDLE WILL NOT FUNCTION PROPERLY. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION AND LOOSEN THE TRIGGER CORD SLIGHTLY IF THE BAND WILL NOT DEPLOY. THE USER IS THEN INSTRUCTED TO RETURN THE HANDLE TO THE FIRING POSITION AND CONTINUE WITH DEPLOYMENT OF THE BAND(S). PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS 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 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 A VARICEAL LIGATION SURGERY, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. AFTER THE FIRST BAND WAS DEPLOYED, THE BAND STUCK TO THE TRIGGER CORD. WHEN BACKFORWARDING THE ENDOSCOPE, THE BAND MOVED BACK ACCORDINGLY. DEPLOYED THE REMAINING 5 BANDS AND REMOVED THE ENDOSCOPE. THEY CHANGED TO ANOTHER PRODUCT TO FINISH THE PROCEDURE. 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
    177292 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3243060

    Patients

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