BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3173147 · Received June 5, 2013

    Report

    Report Number
    1037905-2013-00365
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE WAS NOT VISIBLE IN THE COMPONENT ATTACHMENT INDICATING THE HOOK HAS BROKEN AT THE DISTAL END OF THE DRIVE WIRE. THE CLIP WAS REMOVED AND THE BROKEN PORTION OF THE HOOK WAS NOT LOCATED WITHIN THE CLIP HOUSING. THEREFORE THE BROKEN PORTION OF THE HOOK WAS NOT RETURNED WITH THE DEVICE. THE DRIVE WIRE IS SECURELY ATTACHED TO THE HANDLE. 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 WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: RESISTANCE ENCOUNTERED WHILE ATTEMPTING TO DEPLOY THE CLIP AFTER THE CLIP IS CLOSED ON THE TISSUE (I.E. DIFFICULTY WITH CLIP RELEASE) CAN LEAD TO DAMAGE OF DEVICE COMPONENTS SUCH AS THE HOOK AT THE DISTAL END OF THE DRIVE WIRE OR THE SECURITY OF THE DRIVE WIRE TO THE HANDLE. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO VERIFY SMOOTH HANDLE OPERATION AND CLIP OPERATION PRIOR TO USE. THE INSTRUCTIONS FOR USE STATES: IF CLIP DEPLOYMENT DEVICE IS USED WITH ENDOSCOPE IN A TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR. THE INSTRUCTIONS FOR USE STATES: THIS DEVICE IS NOT INTENDED FOR REPAIR OF GI TRACT LUMINAL PERFORATIONS. PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS 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 CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE IN THE ASCENDING COLON, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. THERE WERE 4 SEPARATE 3MM PERFORATIONS IN SUCCESSION IN THE ASCENDING COLON [THIS IS OUTSIDE THE INTENDED USE]. THE CLIP WAS ATTACHED TO THE TISSUE SITE. THE CLIP WOULD NOT DEPLOY; IT WOULD NOT DETACH [RELEASE] FROM THE CATHETER [OF THE CLIP DEPLOYMENT DEVICE]. THEY WERE UNABLE TO REOPEN THE CLIP FOR REMOVAL FROM THE TISSUE SITE. THE CLIP WAS FORCEFULLY AND MANUALLY PULLED OFF THE TARGETED SITE AND REMOVED THROUGH THE ENDOSCOPE. 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
    249526 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257137

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE PCF (B)(4)