BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 18025916 · Received October 27, 2023

    Report

    Report Number
    1037905-2023-00521
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 4, 2023
    Report Date
    December 11, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITHIN 30 DAYS OF THIS SUBMISSION.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITHIN 30 DAYS OF THIS SUBMISSION.

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. THE DEVICE WAS RETURNED IN A 3 COIL POSITION. A VISUAL EXAMINATION CONFIRMED THAT THE CLIP HOUSING HAD SEPARATED FROM THE CATH ATTACH BUT REMAINS ATTACHED TO THE DRIVE WIRE IN THE CLOSED POSITION. ONE OF THE JAWS ALSO APPEARS TO BE BENT OUTWARD, CAUSING CLIP JAWS NOT TO CLOSE FULLY. THE CLIP WAS MANUALLY OPENED AND THE JAW WAS BENT APPROXIMATELY IN THE MIDDLE. THE COIL CATH WAS ALSO DEFORMED AND THE DRIVE WIRE WAS BENT. THE DEVICE WAS NOT FUNCTION TESTED IN THE SCOPE DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION, AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE DEVICE CONFIRMS THAT THE HOUSING WAS DETACHED FROM THE CATH ATTACH. ADDITIONALLY THE COIL CATH HAS BEEN DEFORMED AND THE JAWS ARE NOT EVENLY STRAIGHT INSIDE THE HOUSING. THE OUTER SHEATH HAS NO SIGNS OF DAMAGE OR TEARS. THE HANDLE COMPONENTS ARE ALL INTACT WITH NO SIGNS OF MANIPULATION OR WEAR. THE DEVICE WAS UNABLE TO UNDERGO FUNCTIONAL TESTING BASED UPON THE STATE AT WHICH IT WAS RECEIVED. THE JAWS WERE MANIPULATED TO VERIFY IF THEY WERE UNABLE TO FULLY OPEN. THIS WAS CONFIRMED AS THE JAWS FACED MUCH DIFFICULTY IN MOVING ALONG THE OPENING PATH. THE REPORTED COMPLAINT FOR DETACHED CATH ATTACH WAS CONFIRMED THROUGH VISUAL EVALUATION OF THE DEVICE. WITH THE DETACHMENT OF THE CATH ATTACH, DEPLOYMENT OF THE CLIP IS UNACHIEVABLE. PER STANDARD PROCEDURES, ALL INSTINCT PLUS DEVICES ARE TESTED FOR OPENING AND CLOSING OF THE CLIP. ALL UNSATISFACTORY SEATING OF THE CATH ATTACH WOULD BE DETECTED AT THIS STEP, ALONG WITH ANY UNSATISFACTORY JAW FORMATION/POSITIONING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND RELEVANT DEFECTS WERE NOTED IN THE MANUFACTURING/FQC CHECKLISTS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO THE COMPLAINT WERE CONTAINED IN THE ASSOCIATED DHR. THE NONCONFORMANCE DOCUMENTATION SUPPORTS THE AFFECTED DEVICE(S) WERE DISPOSITIONED APPROPRIATELY PRIOR TO RELEASE OF THIS LOT. THERE IS NO EVIDENCE NONCONFORMING PRODUCT WAS RELEASED FOR DISTRIBUTION. IN AN EFFORT TO HEIGHTEN AWARENESS OF THE POTENTIAL CONNECTION OF THE CUSTOMERS REPORT TO THE CURRENT MANUFACTURING PROCESSES PRODUCTION PERSONNEL WERE NOTIFIED. INVESTIGATION CONCLUSION: THE SUPPLIER PROVIDED THE FOLLOWING, "THE COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED, NO CORRECTIVE ACTION ASSIGNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ANY RELEVANT DEFECT HAS BEEN DOCUMENTED. A VISUAL EVALUATION OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT. ROOT CAUSE COULD NOT BE DETERMINED. THERE IS A 100% VERIFICATION FOR CLIP FUNCTIONALITY PRIOR TO PACKAGING AND SHIPMENT." A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF THE CLIP HOUSING DETACHING FROM THE CATH ATTACH FOR INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. THE INSTRUCTIONS FOR USE STATES: "UNCOIL DEVICE. VERIFY SMOOTH HANDLE OPERATION AND CLIP ACTION. OPEN CLIP BY GENTLY MOVING HANDLE SPOOL DISTALLY (AWAY FROM HANDLE THUMB RING). ONCE CLIP IS FULLY OPEN, DO NOT CONTINUE ADVANCING HANDLE SPOOL AS CLIP MAY PREMATURELY DETACH FROM CATHETER. CLOSE CLIP BY MOVING HANDLE SPOOL PROXIMALLY UNTIL CLIP IS FULLY CLOSED. PRECAUTION: DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP." THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. 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. 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 AN ERCP IN THE AMPULLA, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT WHEN CLIP EXITED THE SCOPE THE CLIP ARMS WERE BENT TO THE RIGHT. IT OPENED UP AND THEY WERE ABLE TO GRAB TISSUE BUT THE CLIP WOULD NOT DEPLOY. THEY REMOVED THE CLIP FROM THE SCOPE AND WERE ABLE TO FINISH THE PROCEDURE WITH ANOTHER CLIP. 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
    1917519 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC W4750836 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown