BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3180083 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00399
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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 WAS NEARLY STRAIGHT SO THE HANDLE SPOOL WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE SECURING COMPONENTS 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 OPEN AND CLOSED. A NOTICEABLE 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: THE USER STATED THAT THIS DEVICE WAS USED TO CLIP GASTRIC VARICES. THE INTENDED USE OF THIS DEVICE STATES: THIS DEVICE IS USED FOR ENDOSCOPIC CLIP PLACEMENT WITHIN THE GASTROINTESTINAL TRACT FOR THE PURPOSE OF ENDOSCOPIC MARKING, HEMOSTASIS FOR MUCOSAL/SUBMUCOSAL DEFECTS LESS THAN 3 CM IN THE UPPER GI TRACT, BLEEDING ULCERS, ARTERIES LESS THAN 2 MM, AND POLYPS LESS THAN 1.5 CM IN DIAMETER IN THE GI TRACT. THIS DEVICE IS NOT INTENDED FOR THE REPAIR OF GI TRACT LUMINAL PERFORATIONS. 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. INSTRUCTIONS FOR USE STATES IF CLIP DEPLOYMENT DEVICE IS USED WITH ENDOSCOPE IN A TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR. 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PT WAS CLIPPED FOR GASTRIC VARICES WITH COOK INSTINCT ENDOSCOPIC HEMOCLIPS. [GASTRIC VARICES ARE OUTSIDE THE INTENDED USE FOR THIS DEVICE.] THE FIRST CLIP WAS USED WITH NO PROBLEM. THE SECOND HEMOCLIP WAS PLACED THROUGH THE ENDOSCOPE AND ABLE TO BE CLOSED ONTO THE TISSUE. THE DRIVE WIRE DISCONNECTED FROM THE HANDLE. ONCE THIS OCCURRED, THE CLIP RELEASED BY OPENING OFF THE TISSUE. SEE MDR 1037905-2013-00398. THE THIRD HEMOCLIP PERFORMED THE SAME AS THE SECOND CLIP. SEE MDR 1037905-2013-00399. A CLIP MADE BY ANOTHER COMPANY WAS USED SUCCESSFULLY TO COMPLETE 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
    269568 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257183

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON RESOLUTION CLIP| OLYMPUS ENDOSCOPE (UNKNOWN TYPE)