BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 16626798 · Received March 28, 2023

    Report

    Report Number
    1037905-2023-00140
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 28, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A BIOHAZARD BAG WITH 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. 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. A FUNCTION TEST WAS ATTEMPTED, IN ORDER TO DEPLOY THE CLIP. WITH HANDLE MANIPULATION THE CLIP DEPLOYED, WITH SIGNIFICANT RESISTANCE ENCOUNTERED DURING DEPLOYMENT. THE DEVICE WAS THEN ADVANCED INTO THE ACCESSORY CHANNEL OF A OLYMPUS GASTROSCOPE (2.8MM CHANNEL, GIF-020) WHICH WAS PLACED IN A SIMULATED UPPER GI POSITION. THE TIP OF THE SCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. WITH HANDLE MANIPULATION, THE DRIVE WIRE MOVED FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE CLIP, 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: A CORRECTIVE ACTION 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.¿ THE IFU ALSO INCLUDES THE FOLLOWING PRECAUTION: ¿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 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 A GASTROSCOPY, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE CLIP WAS CLOSED ON THE TARGET TISSUE BUT THEY WERE UNABLE TO DEPLOY THE CLIP. THE MIDDLE METAL SHAFT WAS VISIBLE HANGING ON AT THE END OF THE CLIP QUITE A DISTANCE [MOVED IN A TROMBONING MANNER]. THEY WERE EVENTUALLY ABLE TO OPEN THE CLIP TO REMOVE IT FROM THE TISSUE AND REMOVE THROUGH THE SCOPE CHANNEL. BECAUSE OF THE REBLEEDING [THE PHYSICIAN] PUT SOME MORE ADRENALINE IN BETWEEN THIS TO IMPROVE VISUALISATION AND FIND THE CORRECT LOCATION TO CLOSE AGAIN. ANOTHER INSTINCT PLUS WAS USED TO COMPLETE THE PROCEDURE. 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
    426906 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4643124 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention OLYMPUS SCOPE UNKNOWN MODEL.