BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13569891 · Received February 21, 2022

    Report

    Report Number
    1037905-2022-00075
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 21, 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: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. HOWEVER, 4 SEALED DEVICES FROM THE LOT NUMBER SAID TO BE INVOLVED, 5 SEALED DEVICES FROM LOT W4454373, AND 7 SEALED DEVICES FROM LOT W4502464 WERE RETURNED AND EVALUATED. SEALED DEVICES FROM LOT NUMBER SAID TO BE INVOLVED: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES, FROM THE SAME LOT NUMBER AS THE USED DEVICES, CONFIRMED THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLES WERE 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 CLIPS OPENED AND CLOSED BUT WOULD NOT DEPLOY. DURING THE REMOVAL OF THE DEVICES FROM THE SCOPE EACH OF THE CLIPS DETACHED IN A CLOSED POSITION. A RCB-220-S DEVICE WAS USED TO PUSH THE DEPLOYED CLIP OUT OF THE SCOPE. SEALED DEVICES FROM LOT W4454373: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES, FROM THE ADDITIONAL LOT NUMBER, CONFIRMED THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLES WERE 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 CLIPS OPENED AND CLOSED BUT WOULD NOT DEPLOY. DURING THE REMOVAL OF THE DEVICES FROM THE SCOPE EACH OF THE CLIPS DETACHED IN A CLOSED POSITION. SEALED DEVICES FROM LOT W4502464: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES, FROM THE ADDITIONAL LOT NUMBER, CONFIRMED THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLES WERE 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 CLIPS OPENED AND CLOSED BUT WOULD NOT DEPLOY. DURING THE REMOVAL OF THE DEVICES 2-7 FROM THE SCOPE EACH OF THE CLIPS DETACHED IN A CLOSED POSITION. DEVICE 1 WAS REMOVED FROM THE SCOPE WITH THE CLIP ATTACHED IN THE CLOSED POSITION, THE CLIP HOUSING HAD DETACHED FROM THE CATH ATTACH BUT REMAINS ATTACHED TO THE DRIVE WIRE. WITH HANDLE MANIPULATION AND LIGHT TOUCHING OF THE CLIP ON THE TABLE, THE DEVICE DEPLOYED THE CLIP IN A CLOSED POSITION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE FOR DRIVER CRIMP FAILED VERIFICATION, THAT COULD POTENTIALLY BE RELATED TO UNABLE TO DEPLOY. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE UNUSED RETURNED DEVICES. 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 (TRANSVERSE 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
    2401468 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4469912 00827002580107

    Patients

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