BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12737879 · Received November 2, 2021

    Report

    Report Number
    1037905-2021-00601
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 2, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510(K): K192697 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. 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 · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY PERORAL ENDOSCOPIC MYOTOMY (EGD POEM) PROCEDURE, FOUR COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES WERE USED. IT WAS DIFFICULT TO GET THE CLIPS TO DEPLOY FROM THE DRIVE WIRES. WHEN MANIPULATING THE DEVICES TO GET THE CLIPS TO DEPLOY, EXTRA BLEEDING OCCURRED. THE CLIPS DID EVENTUALLY DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH COMPETITIVE CLIPS. ADDITIONAL INFORMATION RECEIVED STATES THAT THE CLIPS WERE ATTACHED TO TISSUE AND DIFFICULT TO DEPLOY. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED ADDITIONAL CLIPS DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED ADVERSE EFFECTS DUE TO THIS OCCURRENCE THAT WERE CAUSED OR CONTRIBUTED TO BY THE PRODUCT. EXTRA BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637333 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE, UNKNOWN MAKE OR MODEL