BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12419020 · Received September 2, 2021

    Report

    Report Number
    1037905-2021-00473
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 30, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER; OCCUPATION: GI MANAGER. SECTION G: 510K: 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 WAS CONFIRMED BASED ON THE SEALED DEVICES RETURNED. THIRTY-SEVEN SEALED DEVICES FROM FIVE DIFFERENT LOTS WERE RETURNED. OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES CONFIRMED THE REPORT OF UNABLE TO DEPLOY OR OPEN CLIP FROM TISSUE. 13 SEALED DEVICES FROM THE LOT #W4453097: 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. EIGHT OF THE SEALED DEVICES DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY WHICH CONFIRMS THE REPORTED DIFFICULTY. 13 SEALED DEVICES FROM THE LOT #W4458045: 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. FOUR OF THE SEALED DEVICES DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY WHICH CONFIRMS THE REPORTED DIFFICULTY. 1 SEALED DEVICE FROM THE LOT #W4459517: 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. THE SEALED DEVICE DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY WHICH CONFIRMS THE REPORTED DIFFICULTY. 3 SEALED DEVICES FROM THE LOT #W4455543: 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 OF THE SEALED DEVICES DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY WHICH CONFIRMS THE REPORTED DIFFICULTY. 7 SEALED DEVICES FROM THE LOT #W4452379: 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. FIVE OF THE SEALED DEVICES DID REQUIRE ENDOSCOPIC MANEUVERS TO AID IN DEPLOYMENT BUT DID DEPLOY WHICH CONFIRMS THE REPORTED DIFFICULTY. 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: 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 IS INCLUDED IN THE SCOPE 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: GI MANAGER. 510K: K192697. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY WITH POLYPECTOMY, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT AS THE PHYSICIAN WAS CLOSING THE DEVICE AND ATTEMPTING TO DEPLOY, THE CLIP WOULD NOT RELEASE FROM THE DRIVE WIRE. THE PHYSICIAN ATTEMPTED TO OPEN AND CLOSE [THE CLIP] WHICH DID NOT WORK. THE PHYSICIAN ATTEMPTED TO ROTATE TO RELIEVE PRESSURE WHICH DID NOT WORK. THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER AWAY FROM THE TISSUE WHICH PULLED THE CLIP AS WELL AND ALMOST TORE THE TISSUE. IT [CLIP] DID NOT TEAR THE TISSUE. IT [CLIP] EVENTUALLY THEN DEPLOYED ONTO THE TARGET SITE. 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
    1316478 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE - OLYMPUS 190 PCF.