BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3190564 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00412
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 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 EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED FOUND THE DRIVE WIRE SEPARATED INSIDE THE HANDLE. THE PROXIMAL END OF THE DRIVE WIRE WAS BOWED, INDICATING PROPER ASSEMBLY OF THE SECURING COMPONENT. USING HEMOSTATS TO GRASP THE DRIVE WIRE, THE CLIP WAS OPENED AND CLOSED. A SLIGHT 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 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 CORRECTLY MANUFACTURED. 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 LAB 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. 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE TO TREAT AN ESOPHAGEAL BLEED, THE PT WAS REPORTEDLY LOSING BLOOD RAPIDLY. THE PHYSICIAN WAS VERY NERVOUS AND NEEDED A HEMOSTASIS DEVICE TO PERFORM. ARGON PLASMA COAGULATION (APC) WAS TRIED FIRST BUT THIS DID NOT WORK. THE PHYSICIAN SWITCHED TO A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE ENDOSCOPE WAS IN A STRAIGHT POSITION. THE CLIP FAILED TO OPEN. THE CLIP WAS REMOVED FROM THE ENDOSCOPE. OUR LAB EVAL CONFIRMED THE DRIVE WIRE BROKE AT THE DISTAL END, WHICH IS NEAR THE CLIP HOUSING. SEE MDR 1037905-2013-00411. THE PHYSICIAN THEN USED A SECOND COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WAS ADVANCED THROUGH THE ENDOSCOPE AND CLOSED ONTO THE BLEEDING SITE. THE HANDLE WAS SLOWLY CLOSED AND WHEN THE USER WAS READY FOR DEPLOYMENT, THE DRIVE WIRE BROKE AT THE HANDLE. THE CLIP WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. AFTER PULLING ON THE DRIVE WIRE, THE CLIP WAS ABLE TO BE REOPENED. THE CLIP WAS REMOVED FROM THE ENDOSCOPE IN THE OPENED POSITION. WE REQUESTED INFORMATION REGARDING HOW THE PROCEDURE WAS FINISHED, BUT THIS WAS UNABLE TO BE PROVIDED BY THE MEDICAL FACILITY. 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
    269899 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3257183

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE (UNK TYPE)