BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12206880 · Received July 21, 2021

    Report

    Report Number
    1037905-2021-00335
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 21, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/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. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. THE CLIPS MADE CONTACT WITH THE POLYP SITE. WHEN THEY WENT TO DEPLOY THE CLIP, THE CLIP DEPLOYED BUT IT WAS STILL ATTACHED TO THE DRIVE WIRE AND IT WOULD NOT RELEASE. THE PHYSICIAN HAD TO JIGGLE THE CATHETER AND THE NURSE OPENED AND CLOSED THE HANDLES TO TRY TO REMOVE THE WIRE FROM THE CLIPS THEMSELVES. THEY STATED THAT BY OPENING AND CLOSING THE CLIPS TO SHAKE THEM LOOSE, THE DRIVE WIRE MANIPULATION PUNCTURED THE TISSUE AREA AND CAUSED MORE BLEEDING. CLIPS DID DETACH (AND STAYED ON TISSUE) DUE TO THE MANIPULATION. BLEEDING WAS STOPPED WITH THE FINAL 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 EXPERIENCED A PUNCTURE AND ADDITIONAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100168 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4416642 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention