BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 20352908 · Received October 2, 2024

    Report

    Report Number
    1037905-2024-00601
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 23, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K212323. THE INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW UP EMDR WITHIN 30 DAYS OF 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 TWO OPEN POUCHES FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABELS MATCH THE PRODUCTS RETURNED. DEVICES #1 - #2: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE ALL THE DEVICE COMPONENTS (PARTICULARLY THE CLIP) WERE NOT INCLUDED IN THE RETURN. DURING FUNCTIONAL TESTING THE DEVICE WERE ADVANCED INTO THE ACCESSORY CHANNEL OF A PENTAX COLONOSCOPE (2.8 MM 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 WIRE WAS OBSERVED TO MOVE FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DRIVE WIRE, CATHETER ATTACHMENT, AND COIL CATHETER (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: OUR LABORATORY EVALUATION OF THE PRODUCTS SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCTS SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION, THE CLIPS HAD BEEN DEPLOYED AND WERE NOT INCLUDED IN THE RETURN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING: "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." IFU ALSO CONTAINS THE FOLLOWING PRECAUTIONS: "DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP. FAILURE TO KEEP ENDOSCOPE AS STRAIGHT AS POSSIBLE WHEN INSERTING DEVICE CAN RESULT IN DIFFICULT PASSAGE.¿ THE INSTRUCTIONS FOR USE ALSO STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE, DUODENOSCOPE, OR COLONOSCOPE.¿ 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. 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 WOUND CLOSURE AFTER A POLYPECTOMY IN THE STOMACH, THE PHYSICIAN USED TWO COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS REPORTED THAT THE CLIP RELEASED BEFOREHAND IN THE WORKING CHANNEL OF THE ENDOSCOPE. THIS ALSO HAPPENED WITH THE SECOND CLIP THEY USED. 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
    34824 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4780279 00827002580107

    Patients

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