BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3161566 · Received May 6, 2013

    Report

    Report Number
    1037905-2013-00378
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE HAS SEPARATED INSIDE THE HANDLE. THE PROXIMAL END OF THE DRIVE WIRE WAS BOWED INDICATING PROPER ASSEMBLY OF THE SECURING COMPONENT. USING HEMOSTASIS TO GRASP THE DRIVE WIRE, THE CLIP WAS OPENED AND CLOSED. AN 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 DEVICE WAS ADVANCED INTO PENTAX EC3830-TL COLONOSCOPE IN A SIMULATED LOWER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. USING THE HEMOSTATS, THE CLIP DID SUCCESSFULLY DEPLOY ON SIMULATED TISSUE. THE DRIVE WIRE WAS REMOVED FROM THE DEVICE, VISUALLY EXAMINED AND DETERMINED THAT THE DRIVE WIRE WAS MANUFACTURED CORRECTLY. THE HOOK OF THE DRIVE WIRE IS INTACT. 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. INSTRUCTIONS FOR USE STATES TO PERMANENTLY DEPLOY CLIP, PULL HANDLE SPOOL TOWARD HANDLE THUMB RING UNTIL CLIP DETACHES. NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP. 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 MFG 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, TWO COOK INSTINCT ENDOSCOPIC HEMOCLIPS WERE USED FOR HEMOSTASIS IN THE COLON. IN EACH CASE, THE CLIPS WERE ATTACHED TO THE MUCOSA BUT THEY WOULD NOT DEPLOY. THE CLIP WOULD NOT RELEASE FROM THE CLIP DEPLOYMENT DEVICE. THE CLIPS STAYED IN THE CLOSED POSITION. THE PHYSICIAN TRIED TO DEPLOY NORMALLY AND HEARD TWO CLICKS. THE DRIVE WIRE BROKE AT THE HANDLE [DRIVE WIRE DISCONNECTED FROM THE HANDLE]. THE PHYSICIAN HAD TO PULL EACH CATHETER AND CLIP OFF THE MUCOSA, WHICH CAUSED ADD'L DAMAGE TO THE CLIPPING SITE. ADD'L CLIPS WERE NEEDED DUE TO THE CLIPS BEING REMOVED FROM THE TISSUE/ADD'L DAMAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. OTHER THAN ADD'L CLIPS APPLIED DURING THE PROCEDURE, THE PATIENT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURENCE. 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
    197739 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3261778

    Patients

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