BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 4241328 · Received September 5, 2014

    Report

    Report Number
    1037905-2014-00345
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FHN
    PMA / PMN Number
    K132809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. THE CLIP JAWS SHOWED PROPER PROCESSING AND THE CLIP OPENED AND CLOSED SMOOTHLY OUTSIDE OF THE COLONOSCOPE. THE DEVICE WAS ADVANCED INTO A PENTAX EC3830-TL COLONOSCOPE IN A SIMULATED LOWER GL POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. ALTHOUGH SLIGHT HESITATION IN OPENING WAS OBSERVED, THE CLIP CLOSED AND SUCCESSFULLY DEPLOYED ON SIMULATED TISSUE WITH A MINIMAL AMOUNT OF FORCE AT THE USER HANDLE. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. INSTRUCTION FOR USE STATE 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. INSTRUCTION FOR USE STATE 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: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. ONCE THE CLIP WAS ATTACHED TO THE CLIPPING SITE, IT WOULD NOT RELEASE FROM THE CATHETER. THE CLIP WAS PULLED OFF OF TARGET SITE IN THE CLOSED POSITION AND REMOVED FROM THE ENDOSCOPE WITH NO HARM TO THE PATIENT. ANOTHER CLIP WAS USED TO COMPLETE THE ORIGINALLY INTENDED PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    546287 INSTINCT ENDOSCOPIC HEMOCLIP FHN, LIGATOR, HEMORRHOIDAL FHN WILSON-COOK MEDICAL INC. W3421948

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS CF-H190 ENDOSCOPE