BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3173459 · Received June 6, 2013

    Report

    Report Number
    1037905-2013-00369
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 26, 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
    TN, 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 BOWED 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 VERIFIED TO BE WITHIN THE APPROPRIATE MFG SPECIFICATION. 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. 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 THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE PHYSICIAN OPENED AND CLOSED THE CLIP SEVERAL TIMES AT THE TARGET SITE TO DETERMINE WHERE TO PLACE THE CLIP. THE CLIP WAS PLACED ON THE TISSUE BUT THE CLIP WOULD NOT SHUT [CLOSE ONTO THE TISSUE]. THE FACILITY BELIEVES THAT THE HANDLE BROKE BECAUSE THE CLIP WOULD NOT DO ANYTHING. ANOTHER COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS OPENED AND USED TO COMPLETE THE PROCEDURE. OUR LABORATORY EVALUATION CONFIRMED THE DRIVE WIRE DISCONNECTED FROM THE HANDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE 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
    251932 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257175

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE GIF-180