BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3173485 · Received June 11, 2013

    Report

    Report Number
    1037902-2013-00381
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED FOUND THE DRIVE WIRE SEPARATED INSIDE THE HANDLE. THE PROXIMAL END OF THE DRIVE WIRE SEEMED TO BE ALTERED BY THE END USER PERHAPS FROM USING HEMOSTATS IN AN ATTEMPT TO DEPLOY THE CLIP. THEREFORE, THE HANDLE SPOOL WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE SECURING COMPONENT TIP. THE TIP SHOWED DEFORMATION WHERE IT CONTACTED THE DRIVE WIRE THUS INDICATING PROPER ASSEMBLY OF THE SECURING COMPONENT. USING HEMOSTATS TO GRASP THE DRIVE WIRE, THE CLIP WAS OPENED AND CLOSED. A SIGNIFICANT 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 OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER 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 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTION ACTION: A CORRECTION 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD), A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. THE PT REQUIRED MULTIPLE CLIPS FOR CLOSURE OF A DEFECT IN THE STOMACH THAT WAS LOCATED ALONG THE POSTERIOR AREA OF THE LESSER CURVE. THE PHYSICIAN PLACED TWO COOK INSTINCT ENDOSCOPIC HEMOCLIPS SUCCESSFULLY. THE THIRD HEMOCLIP WAS CLOSED ONTO THE TISSUE. THE CLIP APPEARED TO HAVE BEEN PLACED, BUT UPON REMOVAL OF THE DEPLOYMENT DEVICE FROM THE SITE, THE CLIP WAS REMOVED AS WELL. ALL INDICATIONS WERE THAT THE CLIP HAD BEEN DEPLOYED SUCCESSFULLY. THE GI TECHNICIAN INDICATED THAT IT FEELS LIKE THE CLIP HANDLE BROKE [DRIVE WIRE DISCONNECTED FROM THE HANDLE]. THE CLIP REOPENED WHEN THE DEPLOYMENT DEVICE WAS REMOVED. THE PHYSICIAN COMMENTED "EASY SITE, NOTHING UNUSUAL OR DIFFICULT REGARDING CLIP PLACEMENT". A CLIP MADE BY ANOTHER COMPANY WAS USED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264802 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257169

    Patients

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