BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13739831 · Received March 11, 2022

    Report

    Report Number
    1037905-2022-00108
    Event Type
    Injury
    Date Received
    March 11, 2022
    Report Date
    March 11, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, 10 SEALED DEVICES FROM THE LOT NUMBER SAID TO BE INVOLVED WERE RETURNED AND EVALUATED. SEALED DEVICES 1-6 AND 8-10: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES CONFIRMED THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLES WERE FUNCTION TESTED PER PROTOCOL STUDY FOR BASELINE 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. DEVICES 1, 2, 4, AND 6 DEPLOYED AS THE DEVICE WAS BEING RETRACTED INTO THE SCOPE. DURING THE REMOVAL OF DEVICES 3, 5, AND 8-10 FROM THE SCOPE EACH OF THE CLIPS DETACHED FROM THE HOUSING IN A CLOSED POSITION WITHIN THE SCOPE. A RCB-220-S DEVICE WAS USED TO PUSH THE DEPLOYED CLIP OUT OF THE SCOPE. SEALED DEVICE 7: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICE, COULD NOT CONFIRM THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLE WAS FUNCTION TESTED PER PROTOCOL STUDY FOR BASELINE FUNCTIONAL TESTING FOR OPEN/CLOSE AND FULL DEPLOYMENT NOT ON SIMULATED TISSUE, TO REPLICATE A WORST CASE SCENARIO. THE CLIP OPENED AND CLOSED, AND DEPLOYED AS INTENDED, NO ENDOSCOPIC MANEUVERS WERE REQUIRED TO AID IN DEPLOYMENT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE 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: 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. SEALED DEVICES 1-6 AND 8-10: DEPLOYMENT DIFFICULTY WAS CONFIRMED. SEALED DEVICE 7: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. 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 POST-POLYP CLOSURE IN THE COLON, FIVE COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES WERE USED. THERE WAS DIFFICULTY RELEASING THE CLIPS FROM THE CLIPPING SITE. THE DEVICES FIRED BUT WERE DIFFICULT TO RELEASE [DIFFICULT TO DEPLOY]. ONE RIPPED OFF AND WAS FIXED WITH AN ADDITIONAL TWO CLIPS. FOUR CLIPS WERE ABLE TO BE RELEASED WITH EXTREME DIFFICULTY. THE ISSUES OCCURRED IN FIVE SEPARATE PROCEDURES. ADDITIONAL INFORMATION RECEIVED STATES THE CLIPS WERE DIFFICULT TO DEPLOY ONCE ATTACHED TO THE TISSUE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE; TWO ADDITIONAL CLIPS WERE REQUIRED TO STOP THE BLEEDING FROM THE CLIP THAT RIPPED OFF. 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
    1185316 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4462061 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention OLYMPUS 180 COLONOSCOPE