BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 14647855 · Received June 9, 2022

    Report

    Report Number
    1037905-2022-00279
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 5, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH PRODUCT EVALUATION INFORMATION.

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR BAG WITH THE OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE PICTURE PROVIDED SHOWS THE DISTAL END OF THE DEVICE AFTER USE, AND THE CLIP HOUSING HAS DETACHED FROM THE CATH ATTACH BUT IS STILL CONNECTED TO THE DRIVE WIRE. THE COIL CATH AND THE DRIVE WIRE ALSO APPEAR TO BE BENT. OUR LABORATORY EVALUATION OF THE PRODUCT 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. THE CLIP COULD NOT BE REOPENED. UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COILED CATH APPEARED TO BE OVERLY CRIMPED/ MISSHAPEN AT THE DISTAL END AND THE CATH ATTACH WAS DEFORMED; THE DRIVE WIRE WAS ALSO BENT. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION. THE FOLLOWING INFORMATION WAS PROVIDED: "UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COILED CATH AND CATH ARE DEFORMED. THE TIP AND CATHETER ASSEMBLY ARE ALSO BENT. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED SINCE FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IN THE MANUFACTURING PROCESS THERE ARE THREE (3) PROCESS STEPS WHICH WOULD DETECT THE DEFORMATION AND BENDING OF THE CATHETER. 1) THERE IS VISUAL VERIFICATION IN THE TAB BEND PROCESS, 2) OPEN AND CLOSE FUNCTION IS VERIFIED ONE EACH DEVICE AFTER THE HANDLE IS ASSEMBLED, AND 3) PRIOR TO PACKAGING THE TIP PROTECTOR IS INSTALLED. SINCE THE TIP ASSEMBLE IS BENT AND MISSHAPEN, EXCESSIVE FORCE WOULD BE DETECTED WHEN INSTALLING THE TIP PROTECTOR. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT." 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: THE SUPPLIER PROVIDED THE FOLLOWING: "THE REPORTED COMPLAINT HAS NOT BEEN CONFIRMED. FUNCTIONAL TESTING OF THE DEVICE COULD NOT BE CONDUCTED DUE TO THE CONDITION OF THE RECEIVED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT REVEAL ANY ANOMALIES. A 100% INSPECTION FOR CLIP FUNCTIONALITY IS PERFORMED PRIOR TO PACKAGING AND SHIPMENT." ALTHOUGH THE SUPPLIER EVALUATION WAS UNABLE TO CONFIRM THE REPORT, THE INTERNAL EVALUATION CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. THE CLIP HOUSING HAS SEPARATED FROM THE COIL CATHETER BUT REMAINS ATTACHED TO THE END OF THE DRIVE WIRE, IN A CLOSED POSITION. THE INSTRUCTIONS FOR USE STATES, "NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP." 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: 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED AN INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE SPHINCTER WAS BLEEDING POST SPHINCTEROTOMY AND SPHINCTEROPLASTY. THE STONES HAD BEEN REMOVED SUCCESSFULLY AND THEY TRIALED THE CLIP. THE ISSUE WAS THE CLIP CLOSED OVER THE CORRECT PLACE BUT WOULD NOT RELEASE FROM THE DELIVERY WIRE. THE CLIP WAS PULLED OFF THE AMPULLA WHICH STARTED TO REBLEED AND ANOTHER CLIP WAS SUCCESSFULLY PLACED ON THE BLEEDING AREA AND HEMOSTASIS WAS ACHIEVED. THE PHOTO DEPICTS TROMBONING. THE CLIP AND DELIVERY SYSTEM WAS REMOVED BY MECHANICAL MEANS AND WITHDRAWN FROM THE PATIENT THROUGH THE SCOPE AND ANOTHER CLIP WAS SUCCESSFULLY APPLIED TO THE AMPULLA AND HEMOSTASIS WAS SUCCESSFUL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN ADDITIONAL CLIP FOR HEMOSTASIS 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
    2218569 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4552621 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention UNKNOWN MODEL OF OLYMPUS SCOPE