BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12067840 · Received June 25, 2021

    Report

    Report Number
    1037905-2021-00272
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 25, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: DIRECTOR. PMA/510(K) # K192697 INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES DID NOT CONFIRM THE REPORT OF UNABLE TO DEPLOY OR OPEN CLIP FROM TISSUE. SIX (6) SEALED DEVICES FROM THE SAME LOT: THE SAMPLES WERE FUNCTION TESTED PER TEST PROTOCOL FOR OPEN/CLOSE AND FULL DEPLOYMENT ON SIMULATED TISSUE. THE CLIPS OPENED AND CLOSED, AND DEPLOYED AS INTENDED ON SIMULATED TISSUE. TWO (2) OF THE SEALED DEVICES DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY. 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: SEALED DEVICES, RETURNED: THE 6 SEALED DEVICES WERE TESTED FOR OPEN/CLOSE AND FULL DEPLOYMENT ON SIMULATED TISSUE. THE CLIPS OPENED AND CLOSED, AND DEPLOYED AS INTENDED ON SIMULATED TISSUE. TWO OF THE SEALED DEVICES REQUIRED ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY. THESE MANEUVERS ARE ACCEPTABLE BASED ON THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE STATES "NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP." A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF DEPLOYMENT DIFFICULTY FOR INSTINCT PLUS CLIPS. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE 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. 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

    FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. THE CLIP WAS ATTACHED TO THE DEFECT (ENDOSCOPIC MUCOSAL RESECTION DEFECT) AND THE CLIP WOULD NOT DEPLOY FROM THE CATHETER. THE PHYSICIAN HAD TO TEAR THE CLIP OFF THE TARGET SITE, CAUSING A LARGER TEAR, RESULTING IN NEEDING ADDITIONAL CLIPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED THE USE OF ADDITIONAL CLIPS 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
    965542 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4453102 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE, GIF-190H