BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 20207328 · Received September 12, 2024

    Report

    Report Number
    1037905-2024-00534
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 20, 2024
    Report Date
    October 8, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K212323. THE INVESTIGATION IS ONGOING. A FOLLOW UP EMDR WILL BE SUBMITTED WITHIN 30 DAYS OF THE SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    510(K): K212323. INVESTIGATION EVALUATION: THE PRODUCTS SAID TO BE INVOLVED WERE RETURNED IN A CLEAR PLASTIC BAG WITH THREE OPEN POUCHES FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABELS MATCH THE PRODUCTS RETURNED. DEVICE #1 - #3: OUR LABORATORY EVALUATION OF THE PRODUCTS SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION CONFIRMED THE CLIP HOUSING HAS SEPARATED FROM THE COIL CATHETER BUT REMAINS ATTACHED TO THE END OF THE DRIVE WIRE, IN A CLOSED POSITION ON ALL THREE CLIPS. A FUNCTION TEST WAS ATTEMPTED, IN ORDER TO DEPLOY THE CLIPS. WITH HANDLE MANIPULATION THE CLIPS DEPLOYED, WITH SIGNIFICANT RESISTANCE ENCOUNTERED DURING DEPLOYMENT. THE DEVICES WERE THEN ADVANCED INTO THE ACCESSORY CHANNEL OF A PENTAX COLONOSCOPE (2.8MM CHANNEL) WHICH WAS PLACED IN A SIMULATED LOWER GI POSITION. THE TIP OF THE SCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. WITH HANDLE MANIPULATION, THE DRIVE WIRES MOVED FREELY INSIDE THE OUTER SHEATHS. A VISUAL EXAMINATION OF THE CLIPS, CATHETER ATTACHMENTS, AND COIL CATHETERS (DISTAL END DEVICE COMPONENTS) SHOWED NO DEFORMITIES OR SIGNS OF DAMAGE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. 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: DEVICES #1 - #3: OUR EVALUATION OF THE DEVICES CONFIRMED THE REPORT. 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, DUODENOSCOPE, OR COLONOSCOPE. NOTE: IF DIFFICULT TO ADVANCE DEVICE, RELAX ELEVATOR AND/OR STRAIGHTEN ENDOSCOPE.¿. 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 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 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 CLOSING OF SCAR IN ANTRO [CLIPPING A DEFECT IN THE STOMACH], THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE CLIPS DO NOT COME LOOSE. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE CLIPS TROMBONED [CLIP HOUSING DETACHED FROM THE CATH ATTACH BUT REMAINED ATTACHED TO THE DRIVE WIRE]. A 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
    1516768 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4823496 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OLYMPUS SCOPE, UNKNOWN MODEL.