BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13571823 · Received February 21, 2022

    Report

    Report Number
    1037905-2022-00077
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 18, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K192697. THE INVESTIGATION IS ONGOING. A FOLLOW UP EMDR REPORT WILL BE SENT WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT FOR THE DEVICE EVALUATION AND COMPLETED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    510(K): K192697. INVESTIGATION EVALUATION: THE PRODUCTS SAID TO BE INVOLVED WERE RETURNED IN OPEN POUCHES FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABELS MATCH THE PRODUCTS RETURNED. ONE ADDITIONAL SEALED DEVICE FROM THE LOT NUMBER PROVIDED WAS ALSO INCLUDED IN THE RETURN. USED DEVICES: OUR LABORATORY EVALUATION OF THE PRODUCTS SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE ALL THE DEVICE COMPONENTS (PARTICULARLY THE CLIPS) WERE NOT INCLUDED IN THE RETURN. DURING FUNCTIONAL TESTING EACH DEVICE WAS ADVANCED INTO THE ACCESSORY CHANNEL OF A PENTAX COLONOSCOPE (2.8 MM CHANNEL) WHICH WAS PLACED IN A SIMULATED LOWER GI POSITION. THE TIP OF THE ENDOSCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. WITH HANDLE MANIPULATION, THE DRIVE WIRE WAS OBSERVED TO MOVE FREELY INSIDE THE OUTER SHEATH OF BOTH DEVICES. A VISUAL EXAMINATION OF THE DRIVE WIRE, CATHETER ATTACHMENT, AND COIL CATHETER (DISTAL END DEVICE COMPONENTS) SHOWED NO DEFORMITIES OR SIGNS OF DAMAGE ON EITHER DEVICE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. SEALED DEVICE FROM LOT NUMBER SAID TO BE INVOLVED: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICE, FROM THE SAME LOT NUMBER AS THE USED DEVICES, CONFIRMED THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLE WAS FUNCTION TESTED PER PROTOCOL STUDY FOR FUNCTIONAL TESTING FOR OPEN/CLOSE AND FULL DEPLOYMENT NOT ON SIMULATED TISSUE, TO REPLICATE A WORST CASE SCENARIO. THE CLIP OPENED AND CLOSED BUT WOULD NOT DEPLOY. DURING THE REMOVAL OF THE DEVICE THROUGH THE SCOPE THE CLIP DETACHED IN A CLOSED POSITION. 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 CONCLUSION: A FULL EVALUATION OF THE RETURNED USED DEVICE WAS NOT POSSIBLE AS NOT ALL OF THE DEVICE COMPONENTS WERE NOT INCLUDED IN THE RETURN. THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNUSED DEVICE. THE DEVICES DID NOT DEPLOY AS INTENDED. A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF DEPLOYMENT DIFFICULTY FOR INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES 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 AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING A COLONOSCOPY W/ EMR (SIGMOID COLON), A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE WAS USED. WHEN THE CLIP WAS ADVANCED THROUGH THE ENDOSCOPE, THE USER CLOSED THE CLIP AND THE CLIP WOULD NOT RELEASE OR SEPARATE FROM THE HOUSING. THE PHYSICIAN HAD TO SHAKE THE DEVICES UNTIL THE RELEASED [DIFFICULT TO DEPLOY]. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY 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
    2402551 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4458048 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS CF-190 SCOPE.